<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03002597</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19080134</org_study_id>
    <nct_id>NCT03002597</nct_id>
  </id_info>
  <brief_title>Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children</brief_title>
  <official_title>Visual Information Restoration and Rehabilitation Via Sensory Substitution Technology in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ellen Mitchell</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <brief_summary>
    <textblock>
      The BrainPort vision device is a visual prosthetic designed for those who are blind. It&#xD;
      enables perception of visual information using the tongue and camera system as a paired&#xD;
      substitute for the eye. Visual information is collected from a video camera and translated&#xD;
      into a gentle vibration that is presented to the subject on the tongue. With training users&#xD;
      perceive shape, size, location and motion of objects in their environment. It is a&#xD;
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.&#xD;
&#xD;
      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision&#xD;
      device) that enables the blind to appreciate their immediate surroundings and determine the&#xD;
      way the brain interprets the information. Our goal is to determine if the device can be used&#xD;
      in a pediatric population by measuring the subjects' improvement over baseline in any of the&#xD;
      following areas: light detection, light localization, movement perception, and standardized&#xD;
      object recognition tasks after use of the BrainPort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      Our objective is to determine if the functional improvements seen in blind subjects using the&#xD;
      BrainPort can be realized in a pediatric cohort.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision&#xD;
      device) that enables the blind to appreciate their immediate surroundings and determine the&#xD;
      way the brain interprets the information. Our main goal is to determine if the device can be&#xD;
      used in a pediatric population by measuring the subjects' improvement over baseline in any of&#xD;
      the following areas: light detection, light localization, movement perception, and&#xD;
      standardized object recognition tasks after use of the BrainPort.&#xD;
&#xD;
      As a second aim, the investigators will use a multimodal MR scanning session to study the&#xD;
      neurophysiological basis of sensory substitution in children. Under this aim the&#xD;
      investigators will pursue two main objectives. First, the investigators will correlate the&#xD;
      behavioral data with the imaging data in order to detect regions of the brain where structure&#xD;
      and/or function are associated with successful use of sensory substitution devices. Second,&#xD;
      the investigators will utilize these data along with previously collected adult data to model&#xD;
      the effects of prior visual experience on visual cortex plasticity due to blindness.&#xD;
&#xD;
      Background:&#xD;
&#xD;
      The BrainPort vision device is a visual prosthetic designed for those who are blind. It&#xD;
      enables perception of visual information using the tongue and camera system as a paired&#xD;
      substitute for the eye. Visual information is collected from a video camera and translated&#xD;
      into gentle electrical stimulation patterns on the surface of the tongue. With training,&#xD;
      users perceive shape, size, location and motion of objects in their environment. It is a&#xD;
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.&#xD;
&#xD;
      Tactile sensory systems have proven capable of carrying information to the brain that is&#xD;
      usually acquired visually. Braille and the long cane have provided such information to blind&#xD;
      persons for decades, and in the 1960's it was clearly demonstrated that tactile inputs could&#xD;
      provide access to written print1 and visual images2. The main limitation to the development&#xD;
      of practical vision substitution has been the inadequacy of brain-machine interfaces.&#xD;
      Thirty-five years ago Paul Bach-y-Rita, MD wrote &quot;That a successful sensory substitution&#xD;
      system is not presently in use may not be due to limited functional capabilities of the&#xD;
      brain; it may be due to the fact that an artificial receptor system has not yet been&#xD;
      constructed to challenge the adaptive capacities of the human brain&quot;3.&#xD;
&#xD;
      BrainPort Vision Device Since 1998, Wicab has focused on biomedical engineering research and&#xD;
      development of commercial devices based on its proprietary BrainPort® technology4. The&#xD;
      BrainPort vision device is a visual prosthetic designed for those who are blind.&#xD;
&#xD;
      Numerous previous studies support using the tongue as a sensory substitution channel2,3,5-8.&#xD;
      Our and others' research has revealed that the brain can correctly interpret information from&#xD;
      a sensory substitution device, even when the information is not presented in the same pathway&#xD;
      as the natural sensory system. For example, the optical image actually received by the eye&#xD;
      travels no farther than the retina, which converts the image into spatio-temporal patterns of&#xD;
      action potentials along the optic nerve fibers. By analyzing these impulse patterns, the&#xD;
      brain recreates the image. These impulses are not unique for vision. In fact, all sensory&#xD;
      systems code information using the same 'language': neuronal action potentials. Using the&#xD;
      vision example as a paradigm, sensory substitution requires only that action potentials be&#xD;
      accurately entrained in the alternate sensory information channel. With training, the brain&#xD;
      may learn to appropriately interpret information from the alternate channel and then to&#xD;
      process that information much as it would data from the intact natural sense. Therefore, this&#xD;
      technology benefits users by stimulating the tongue with usable information about their&#xD;
      environment, which some users have described as resembling vision.&#xD;
&#xD;
      Although BrainPort technology stimulates the tongue through the electrode array, the&#xD;
      stimulation is not at all painful; a BrainPort device emits only 11.85 µJ per pulse&#xD;
      (regulatory limit for cutaneously electrical stimulating devices: 300 mJ). In fact, users&#xD;
      often report the sensation as being like champagne bubbles effervescing on the tongue.&#xD;
      Participants using BrainPort devices, whether for several hours each day over the course of a&#xD;
      few weeks or for 20 minutes a day for up to one year, report no discomfort.&#xD;
&#xD;
      Little work has been done using imaging to study blind children. Werth and Seelos used fMRI&#xD;
      to measure evoked activity in the visual cortex of children as evidence of visual function&#xD;
      improvement following field training (Neurpsychologica. 2005. 43(14): 2011). However, to our&#xD;
      knowledge, imaging of blind children to assess plasticity of the visual cortex at such a&#xD;
      young age has not been done. In the short term, imaging of these subjects may improve our&#xD;
      ability to screen for patients who would benefit from sensory substitution devices as well as&#xD;
      to evaluate training paradigms. In the long term, understanding plasticity due to visual&#xD;
      deprivation will be important not just for sensory substitution, but for all vision&#xD;
      restoration strategies in order to identify subjects still capable of processing visual&#xD;
      input. As the investigators attempt to model the effects of prior visual experience on&#xD;
      plasticity in the visual cortex following blindness, children represent a unique and&#xD;
      essential portion of the sample to tease apart the relative effects of blindness duration and&#xD;
      early versus late acquisition.&#xD;
&#xD;
      The BrainPort device has been approved by the FDA since June of 2015.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      The BrainPort vision device is a visual prosthetic designed for those who are blind. It&#xD;
      enables perception of visual information using the tongue and camera system as a paired&#xD;
      substitute for the eye. Visual information is collected from a video camera and translated&#xD;
      into gentle electrical stimulation patterns on the surface of the tongue. With training users&#xD;
      perceive shape, size, location and motion of objects in their environment. It is a&#xD;
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.&#xD;
      The BrainPort vision device is the only new technology likely available in the near term to&#xD;
      address safety and mobility issues resulting from blindness.&#xD;
&#xD;
      Our results have shown that the use of the BrainPort results in behavioral improvements as&#xD;
      well as activation in visual cortical regions using fMRI and PET scans in adults. A trial&#xD;
      which seeks to determine if functional abilities can also be improved in a pediatric cohort&#xD;
      is justifiable for the following reasons:&#xD;
&#xD;
        1. Neuroplasticity is highest in childhood, and the visually deprived brain is likely to be&#xD;
           most receptive to alternative sensory stimulation in this age group.&#xD;
&#xD;
        2. The BrainPort is non-invasive.&#xD;
&#xD;
        3. Other than gene therapy for Leber's Congenital Amaurosis, there are no alternatives to&#xD;
           restoring vision for the blind children at this time.&#xD;
&#xD;
        4. The BrainPort already has CE Mark approval and pending FDA approval (final safety study&#xD;
           documents submitted to the FDA August 2013), and should be available for purchase by&#xD;
           2014, at least in Europe and Canada. Whether the device could be useful in a pediatric&#xD;
           population is an important clinical question.&#xD;
&#xD;
        5. The relation of the anticipated benefit to the risk presented by the study is at least&#xD;
           as favorable to the subjects as that provided by available alternative approaches (blind&#xD;
           training).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Issue reaching target enrollement&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2021</completion_date>
  <primary_completion_date type="Actual">June 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate BrainPort Device</measure>
    <time_frame>5 visits over the course of approximately 2 weeks</time_frame>
    <description>The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Blindness</condition>
  <arm_group>
    <arm_group_label>Blind Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sighted Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children between the ages of 4 and 17 who are sighted in both eyes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BrainPort V200 Device</intervention_name>
    <description>To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.</description>
    <arm_group_label>Blind Children</arm_group_label>
    <arm_group_label>Sighted Children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Blind Children:&#xD;
&#xD;
          1. Between the age of 4 and 17.&#xD;
&#xD;
          2. Blind (documented visual acuity of light perception or worse) in both eyes from an eye&#xD;
             care provider.&#xD;
&#xD;
          3. Able to understand and sign the Informed Consent and Assent form.&#xD;
&#xD;
          4. Able to understand the training and rehabilitation protocols involved in the study.&#xD;
&#xD;
          5. Willing to use the BrainPort device.&#xD;
&#xD;
          6. Able to undergo functional neuroimaging tests&#xD;
&#xD;
        Sighted Children:&#xD;
&#xD;
          1. Between the age of 4 and 17.&#xD;
&#xD;
          2. Sighted in both eyes from an eye care provider.&#xD;
&#xD;
          3. Able to understand and sign the Informed Consent and Assent form.&#xD;
&#xD;
          4. Able to understand the training and rehabilitation protocols involved in the study.&#xD;
&#xD;
          5. Willing to use the BrainPort device.&#xD;
&#xD;
          6. Able to undergo functional neuroimaging tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Blind Children:&#xD;
&#xD;
          1. Current oral health problems as determined by the subject's history, and an&#xD;
             examination of the oral cavity performed by a member of the study team. Subject is&#xD;
             excluded if any of the following conditions are met:&#xD;
&#xD;
               1. A history of injury to the tongue resulting in impaired sensation or use of the&#xD;
                  tongue.&#xD;
&#xD;
               2. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.&#xD;
&#xD;
               3. Oral surgery or dental work in the past 3 months or anticipated to occur for the&#xD;
                  duration of participation in the study (does not include routine dental health&#xD;
                  exams/cleanings).&#xD;
&#xD;
               4. Piercing on the tongue.&#xD;
&#xD;
               5. Performance better than 20/5000 on the FrACT acuity test (same visual criteria as&#xD;
                  FDA safety study).&#xD;
&#xD;
          2. Known neuropathies of tongue or skin tactile system.&#xD;
&#xD;
          3. Unwilling or unable to adhere to all study requirements, including completion of the&#xD;
             training period, evaluation tests and follow up visits.&#xD;
&#xD;
          4. Implanted electrical medical devices such as pacemakers.&#xD;
&#xD;
          5. Known allergies to nickel, gold or other components of stainless steel.&#xD;
&#xD;
          6. Patients who are 18 years and older or younger than 4.&#xD;
&#xD;
          7. Women who are pregnant or breast feeding will not be able to participate in this study&#xD;
             (as indicated by a positive pregnancy test).&#xD;
&#xD;
          8. Children with neurodevelopmental disorders (e.g., autism, learning disabilities) or&#xD;
             congenital brain malformations will be excluded from participation.&#xD;
&#xD;
          9. Cortical blindness from any cause.&#xD;
&#xD;
         10. Claustrophobia that would prevent functional neuroimaging (for those subjects&#xD;
             undergoing neuroimaging only).&#xD;
&#xD;
         11. Obesity preventing placement in MRI scanner (for those subjects undergoing&#xD;
             neuroimaging only).&#xD;
&#xD;
         12. Presence of any foreign metal in the body with the exception of dental fillings.&#xD;
&#xD;
         13. Implanted metallic or ferromagnetic objects (aneurysm clip, ear implant, IUD, shrapnel&#xD;
             or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal&#xD;
             devices).&#xD;
&#xD;
        Sighted Children:&#xD;
&#xD;
          1. Current oral health problems as determined by the subject's history, and an&#xD;
             examination of the oral cavity performed by a member of the study team. Subject is&#xD;
             excluded if any of the following conditions are met:&#xD;
&#xD;
               1. A history of injury to the tongue resulting in impaired sensation or use of the&#xD;
                  tongue.&#xD;
&#xD;
               2. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue.&#xD;
&#xD;
               3. Oral surgery or dental work in the past 3 months or anticipated to occur for the&#xD;
                  duration of participation in the study (does not include routine dental health&#xD;
                  exams/cleanings).&#xD;
&#xD;
               4. Piercing on the tongue.&#xD;
&#xD;
          2. Known neuropathies of tongue or skin tactile system.&#xD;
&#xD;
          3. Unwilling or unable to adhere to all study requirements, including completion of the&#xD;
             training period, evaluation tests and follow up visits.&#xD;
&#xD;
          4. Implanted electrical medical devices such as pacemakers.&#xD;
&#xD;
          5. Known allergies to nickel, gold or other components of stainless steel.&#xD;
&#xD;
          6. Patients who are 18 years and older or younger than 4.&#xD;
&#xD;
          7. Women who are pregnant or breast feeding will not be able to participate in this study&#xD;
             (as indicated by a positive pregnancy test).&#xD;
&#xD;
          8. Children with neurodevelopmental disorders (e.g., autism, learning disabilities) or&#xD;
             congenital brain malformations will be excluded from participation.&#xD;
&#xD;
          9. Cortical blindness from any cause.&#xD;
&#xD;
         10. Claustrophobia that would prevent functional neuroimaging (for those subjects&#xD;
             undergoing neuroimaging only).&#xD;
&#xD;
         11. Obesity preventing placement in MRI scanner (for those subjects undergoing&#xD;
             neuroimaging only).&#xD;
&#xD;
         12. Presence of any foreign metal in the body with the exception of dental fillings.&#xD;
&#xD;
         13. Implanted metallic or ferromagnetic objects (aneurysm clip, ear implant, IUD, shrapnel&#xD;
             or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal&#xD;
             devices).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Mitchell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Eye Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <results_first_submitted>June 29, 2023</results_first_submitted>
  <results_first_submitted_qc>July 25, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2023</results_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Ellen Mitchell</investigator_full_name>
    <investigator_title>Assistant Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blindness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03002597/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03002597/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We were unable to enroll sighted children into the study</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Blind Children</title>
          <description>Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.&#xD;
BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Blind Children</title>
          <description>Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.&#xD;
BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.67" lower_limit="5" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluate BrainPort Device</title>
        <description>The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.</description>
        <time_frame>5 visits over the course of approximately 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Blind Children</title>
            <description>Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.&#xD;
BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate BrainPort Device</title>
          <description>The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.</description>
          <units>percentage of accuracy completing task</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>object identification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.36" spread="20.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>object location</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.47" spread="27.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>light perception</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.99" spread="34.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>location resolution</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" spread="20.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BaGA testing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.86" spread="15.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Blind Children</title>
          <description>Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.&#xD;
BrainPort V200 Device: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kanwal Nischal</name_or_title>
      <organization>Children's Hospital of Pittsburgh UPMC</organization>
      <phone>4126928940</phone>
      <email>nischalkk@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03002597
org study id: STUDY19080134
nct id: NCT03002597
lead sponsor: 
The BrainPort vision device is a visual prosthetic designed for those who are blind. It
      enables perception of visual information using the tongue and camera system as a paired
      substitute for the eye. Visual information is collected from a video camera and translated
      into a gentle vibration that is presented to the subject on the tongue. With training users
      perceive shape, size, location and motion of objects in their environment. It is a
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.

      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision
      device) that enables the blind to appreciate their immediate surroundings and determine the
      way the brain interprets the information. Our goal is to determine if the device can be used
      in a pediatric population by measuring the subjects' improvement over baseline in any of the
      following areas: light detection, light localization, movement perception, and standardized
      object recognition tasks after use of the BrainPort.
Objective:

      Our objective is to determine if the functional improvements seen in blind subjects using the
      BrainPort can be realized in a pediatric cohort.

      Specific Aims:

      The aim of this proposal is to evaluate a non-surgical visual prosthetic (BrainPort vision
      device) that enables the blind to appreciate their immediate surroundings and determine the
      way the brain interprets the information. Our main goal is to determine if the device can be
      used in a pediatric population by measuring the subjects' improvement over baseline in any of
      the following areas: light detection, light localization, movement perception, and
      standardized object recognition tasks after use of the BrainPort.

      As a second aim, the investigators will use a multimodal MR scanning session to study the
      neurophysiological basis of sensory substitution in children. Under this aim the
      investigators will pursue two main objectives. First, the investigators will correlate the
      behavioral data with the imaging data in order to detect regions of the brain where structure
      and/or function are associated with successful use of sensory substitution devices. Second,
      the investigators will utilize these data along with previously collected adult data to model
      the effects of prior visual experience on visual cortex plasticity due to blindness.

      Background:

      The BrainPort vision device is a visual prosthetic designed for those who are blind. It
      enables perception of visual information using the tongue and camera system as a paired
      substitute for the eye. Visual information is collected from a video camera and translated
      into gentle electrical stimulation patterns on the surface of the tongue. With training,
      users perceive shape, size, location and motion of objects in their environment. It is a
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.

      Tactile sensory systems have proven capable of carrying information to the brain that is
      usually acquired visually. Braille and the long cane have provided such information to blind
      persons for decades, and in the 1960's it was clearly demonstrated that tactile inputs could
      provide access to written print1 and visual images2. The main limitation to the development
      of practical vision substitution has been the inadequacy of brain-machine interfaces.
      Thirty-five years ago Paul Bach-y-Rita, MD wrote "That a successful sensory substitution
      system is not presently in use may not be due to limited functional capabilities of the
      brain; it may be due to the fact that an artificial receptor system has not yet been
      constructed to challenge the adaptive capacities of the human brain"3.

      BrainPort Vision Device Since 1998, Wicab has focused on biomedical engineering research and
      development of commercial devices based on its proprietary BrainPort® technology4. The
      BrainPort vision device is a visual prosthetic designed for those who are blind.

      Numerous previous studies support using the tongue as a sensory substitution channel2,3,5-8.
      Our and others' research has revealed that the brain can correctly interpret information from
      a sensory substitution device, even when the information is not presented in the same pathway
      as the natural sensory system. For example, the optical image actually received by the eye
      travels no farther than the retina, which converts the image into spatio-temporal patterns of
      action potentials along the optic nerve fibers. By analyzing these impulse patterns, the
      brain recreates the image. These impulses are not unique for vision. In fact, all sensory
      systems code information using the same 'language': neuronal action potentials. Using the
      vision example as a paradigm, sensory substitution requires only that action potentials be
      accurately entrained in the alternate sensory information channel. With training, the brain
      may learn to appropriately interpret information from the alternate channel and then to
      process that information much as it would data from the intact natural sense. Therefore, this
      technology benefits users by stimulating the tongue with usable information about their
      environment, which some users have described as resembling vision.

      Although BrainPort technology stimulates the tongue through the electrode array, the
      stimulation is not at all painful; a BrainPort device emits only 11.85 µJ per pulse
      (regulatory limit for cutaneously electrical stimulating devices: 300 mJ). In fact, users
      often report the sensation as being like champagne bubbles effervescing on the tongue.
      Participants using BrainPort devices, whether for several hours each day over the course of a
      few weeks or for 20 minutes a day for up to one year, report no discomfort.

      Little work has been done using imaging to study blind children. Werth and Seelos used fMRI
      to measure evoked activity in the visual cortex of children as evidence of visual function
      improvement following field training (Neurpsychologica. 2005. 43(14): 2011). However, to our
      knowledge, imaging of blind children to assess plasticity of the visual cortex at such a
      young age has not been done. In the short term, imaging of these subjects may improve our
      ability to screen for patients who would benefit from sensory substitution devices as well as
      to evaluate training paradigms. In the long term, understanding plasticity due to visual
      deprivation will be important not just for sensory substitution, but for all vision
      restoration strategies in order to identify subjects still capable of processing visual
      input. As the investigators attempt to model the effects of prior visual experience on
      plasticity in the visual cortex following blindness, children represent a unique and
      essential portion of the sample to tease apart the relative effects of blindness duration and
      early versus late acquisition.

      The BrainPort device has been approved by the FDA since June of 2015.

      Significance:

      The BrainPort vision device is a visual prosthetic designed for those who are blind. It
      enables perception of visual information using the tongue and camera system as a paired
      substitute for the eye. Visual information is collected from a video camera and translated
      into gentle electrical stimulation patterns on the surface of the tongue. With training users
      perceive shape, size, location and motion of objects in their environment. It is a
      functional, non-surgical device developed to demonstrate as an aid to the visually impaired.
      The BrainPort vision device is the only new technology likely available in the near term to
      address safety and mobility issues resulting from blindness.

      Our results have shown that the use of the BrainPort results in behavioral improvements as
      well as activation in visual cortical regions using fMRI and PET scans in adults. A trial
      which seeks to determine if functional abilities can also be improved in a pediatric cohort
      is justifiable for the following reasons:

        1. Neuroplasticity is highest in childhood, and the visually deprived brain is likely to be
           most receptive to alternative sensory stimulation in this age group.

        2. The BrainPort is non-invasive.

        3. Other than gene therapy for Leber's Congenital Amaurosis, there are no alternatives to
           restoring vision for the blind children at this time.

        4. The BrainPort already has CE Mark approval and pending FDA approval (final safety study
           documents submitted to the FDA August 2013), and should be available for purchase by
           2014, at least in Europe and Canada. Whether the device could be useful in a pediatric
           population is an important clinical question.

        5. The relation of the anticipated benefit to the risk presented by the study is at least
           as favorable to the subjects as that provided by available alternative approaches (blind
           training).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate BrainPort Device
time frame: 5 visits over the course of approximately 2 weeks
description: The efficacy endpoint for this study is a statistical analysis of subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception (BaGA testing), and standardized object recognition tasks after use of the BrainPort. The mean data reported is the average percentage that participants were able to successfully complete the tested tasks over the 5 visits.
arm group label: Blind Children
arm group type: Experimental
description: Children between the ages of 4 and 17 who are blind (documented visual acuity of light perception or worse) in both eyes from an eye care provider.
arm group label: Sighted Children
arm group type: Experimental
description: Children between the ages of 4 and 17 who are sighted in both eyes.
intervention type: Device
intervention name: BrainPort V200 Device
description: To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.
arm group label: Blind Children
arm group label: Sighted Children
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ellen Mitchell, MD
role: Principal Investigator
affiliation: Assistant Professor of Ophthalmology
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Ellen Mitchell
investigator title: Assistant Professor of Ophthalmology
mesh term: Blindness
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 