<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/NCT03038269</url>
  </required_header>
  <id_info>
    <org_study_id>BRC 467</org_study_id>
    <nct_id>NCT03038269</nct_id>
  </id_info>
  <brief_title>tDCS and Robotic Training in Adults With Cerebral Palsy</brief_title>
  <official_title>Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Burke Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Burke Medical Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve arm function in adults with hemiplegic cerebral&#xD;
      palsy. Participants will receive transcranial direct current stimulation (or sham) in&#xD;
      combination with upper extremity robotic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial&#xD;
      direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training.&#xD;
      Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions).&#xD;
      Before and after therapy, participants will receive and assessment of their arm function, as&#xD;
      well as an assessment of their brain activity, using electroencephalography (EEG) and&#xD;
      transcranial magnetic stimulation (TMS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment of Motor Recovery</measure>
    <time_frame>1 Week</time_frame>
    <description>Evaluates and measures recovery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test</measure>
    <time_frame>1 Week</time_frame>
    <description>Quantifies upper extremity motor ability through timed and functional tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Blocks Test</measure>
    <time_frame>1 Week</time_frame>
    <description>Measures unilateral gross motor dexterity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participant will receive a placebo-type stimulation followed by upper extremity robotic training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Upper Extremity Robotics, tDCS</intervention_name>
    <description>Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant willing and able to provide informed consent&#xD;
&#xD;
          -  Diagnosis of hemiplegic Cerebral Palsy&#xD;
&#xD;
          -  Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal&#xD;
             interphalangeal joints (10 degrees)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive deficits that impede understanding of study protocol&#xD;
&#xD;
          -  Current medical illness unrelated to CP&#xD;
&#xD;
          -  Visual problems (uncorrected by glasses/contact lenses)&#xD;
&#xD;
          -  High motor ability in affected arm&#xD;
&#xD;
          -  Severe spasticity&#xD;
&#xD;
          -  Lack of asymmetry in hand function&#xD;
&#xD;
          -  Orthopedic surgery in affected arm within 2 years&#xD;
&#xD;
          -  Dorsal root rhizotomy&#xD;
&#xD;
          -  Botulinum toxin therapy in either upper extremity during last 2 months, or planned&#xD;
             during study period&#xD;
&#xD;
          -  Currently receiving intrathecal baclofen&#xD;
&#xD;
          -  Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or&#xD;
             first degree relatives), brain surgery, cranial metal implants, structural brain&#xD;
             lesion, deices that may be affected by TMS (pacemaker, medication pump, cochlear&#xD;
             implant, implanted brain stimulator)&#xD;
&#xD;
          -  True positive response on the Transcranial Magnetic Stimulation Safety Screen&#xD;
&#xD;
          -  Current use of medications known to lower the seizure threshold&#xD;
&#xD;
          -  Previous episode of neurocardiogenic snycopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Burke Medical Research Institute</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.</citation>
    <PMID>28505986</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 2, 2022</last_update_submitted>
  <last_update_submitted_qc>October 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Burke Medical Research Institute</investigator_affiliation>
    <investigator_full_name>Kathleen Friel</investigator_full_name>
    <investigator_title>Director, Clinical Laboratory for Early Brain Injury Recovery</investigator_title>
  </responsible_party>
  <keyword>Robotics</keyword>
  <keyword>Upper Extremity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03038269
org study id: BRC 467
nct id: NCT03038269
lead sponsor: 
has dmc: No
The purpose of this study is to improve arm function in adults with hemiplegic cerebral
      palsy. Participants will receive transcranial direct current stimulation (or sham) in
      combination with upper extremity robotic therapy.
Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial
      direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training.
      Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions).
      Before and after therapy, participants will receive and assessment of their arm function, as
      well as an assessment of their brain activity, using electroencephalography (EEG) and
      transcranial magnetic stimulation (TMS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Fugl-Meyer Assessment of Motor Recovery
time frame: 1 Week
description: Evaluates and measures recovery
measure: Wolf Motor Function Test
time frame: 1 Week
description: Quantifies upper extremity motor ability through timed and functional tasks
measure: Box and Blocks Test
time frame: 1 Week
description: Measures unilateral gross motor dexterity.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Participant will receive a placebo-type stimulation followed by upper extremity robotic training.
arm group label: Active tDCS
arm group type: Active Comparator
description: Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.
intervention type: Behavioral
intervention name: Upper Extremity Robotics, tDCS
description: Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.
arm group label: Active tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
citation: Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.
PMID: 28505986
responsible party type: Principal Investigator
investigator affiliation: Burke Medical Research Institute
investigator full name: Kathleen Friel
investigator title: Director, Clinical Laboratory for Early Brain Injury Recovery
mesh term: Cerebral Palsy
mesh term: Hemiplegia
sharing ipd: No