<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/NCT03253718</url>
  </required_header>
  <id_info>
    <org_study_id>170150</org_study_id>
    <secondary_id>17-N-0150</secondary_id>
    <nct_id>NCT03253718</nct_id>
  </id_info>
  <brief_title>Technical Development of Clinical Laboratory Studies</brief_title>
  <official_title>Technical Development of Clinical Laboratory Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The Human Motor Control Section does tests for people with movement disorders. In order to be&#xD;
      sure when a test is normal or abnormal, normal values must be determined in a large group of&#xD;
      healthy volunteers (HVs). Therefore, the researchers want to study the techniques in HVs.&#xD;
      They will use the results as the standard of comparison in future clinical studies.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To get enough normal results in movement tests to use in clinical studies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy adults ages 18-68&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with medical history and physical and neurological exams.&#xD;
&#xD;
      Participants will have 1 to 3 visits. They may have:&#xD;
&#xD;
      Small sticky electrodes attached to the skin on the hands/arms and neck. These will measure&#xD;
      muscle activity.&#xD;
&#xD;
      Tiny shocks given to a finger. Participants will be asked if they felt 1 or 2 shocks. This&#xD;
      will be done to each hand over about 30 minutes total.&#xD;
&#xD;
      A questionnaire about anxiety.&#xD;
&#xD;
      Acoustic startle reflex test. Small electrodes will be stuck to the eye, hand, and leg.&#xD;
      Sensors will be stuck to the palms. Small metal electrodes on the chest and inner arm will&#xD;
      measure heart rate. Participants will wear headphones. Once everything is in place,&#xD;
      participants will hear a low sound for about 10 minutes. They will hear a short louder sound&#xD;
      every 45 60 seconds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      The purpose of this protocol is to get adequate normal values to compare in clinical patient&#xD;
      studies.&#xD;
&#xD;
      Study population&#xD;
&#xD;
      There will be two techniques developed in this study: Somatosensory Temporal Discrimination&#xD;
      Threshold (STDT) and Acoustic Startle Reflex (ASR). For both studies we will collect data&#xD;
      systematically in an adequate sample of normal subjects.&#xD;
&#xD;
      We plan to recruit the following number of healthy volunteers (HV s) for each study.&#xD;
&#xD;
      STDT: 50 HV&#xD;
&#xD;
      ASR: 50 HV&#xD;
&#xD;
      Design&#xD;
&#xD;
      Subjects will come for up to 3 outpatient visits, during which they will participate in at&#xD;
      least the STDT or the ASR. Before participation in any study, all participants will undergo&#xD;
      screening for medical history and physical examination.&#xD;
&#xD;
      For the STDT, the index finger in both hands will be stimulated.&#xD;
&#xD;
      For the ASR, auditory stimulation will be administered at varying intervals. Subjects will&#xD;
      also be asked to complete State Trait Anxiety Inventory (STAI) before participation in the&#xD;
      study.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
      STDT: discrimination threshold value&#xD;
&#xD;
      ASR: EMG response from seven muscles, heart rate, and galvanic skin response&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study withdrawn due to limited personnel, time, resources.&#xD;
  </why_stopped>
  <start_date type="Actual">May 25, 2021</start_date>
  <completion_date type="Actual">May 25, 2021</completion_date>
  <primary_completion_date type="Actual">May 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>STDT values in both hands</measure>
    <time_frame>throughout protocol</time_frame>
    <description>Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The amount, latency and duration of muscle activity, heart rate, and skin conductance.</measure>
    <time_frame>throughout protocol</time_frame>
    <description>Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Healthy Volunteers between 18 and 68 years of age</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HV s will be recruited through NIH Patient Recruitment and Public Liaison Office and from&#xD;
        our database of individuals who have participated in prior studies and are interested in&#xD;
        being contacted for additional studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Between 18 and 68 years of age&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Able to understand the procedures and requirements of the study&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Diagnosis of a neurological disorder&#xD;
&#xD;
          -  Illegal drug use within the past six months. The intent is to exclude those with drug&#xD;
             use that may affect study results&#xD;
&#xD;
          -  Self-reported consumption of &gt;7 alcoholic drinks a week for women and &gt;14 alcoholic&#xD;
             drinks a week for men&#xD;
&#xD;
          -  Unwillingness to abstain from caffeine or alcohol on the day of the study&#xD;
&#xD;
          -  Abnormal findings on neurological exam of clinical significance&#xD;
&#xD;
          -  History of or current brain tumor, stroke, head trauma with loss of consciousness &gt;&#xD;
             few seconds, epilepsy or seizures&#xD;
&#xD;
          -  Open scalp wounds or scalp infections&#xD;
&#xD;
          -  For ASR, unwillingness to abstain from the use of cigarettes on the day of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Hallett, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurological Disorders and Stroke (NINDS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-N-0150.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Volunteers</keyword>
  <!-- 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/NCT03253718
org study id: 170150
secondary id: 17-N-0150
nct id: NCT03253718
lead sponsor: 
is fda regulated drug: No
Background:

      The Human Motor Control Section does tests for people with movement disorders. In order to be
      sure when a test is normal or abnormal, normal values must be determined in a large group of
      healthy volunteers (HVs). Therefore, the researchers want to study the techniques in HVs.
      They will use the results as the standard of comparison in future clinical studies.

      Objective:

      To get enough normal results in movement tests to use in clinical studies.

      Eligibility:

      Healthy adults ages 18-68

      Design:

      Participants will be screened with medical history and physical and neurological exams.

      Participants will have 1 to 3 visits. They may have:

      Small sticky electrodes attached to the skin on the hands/arms and neck. These will measure
      muscle activity.

      Tiny shocks given to a finger. Participants will be asked if they felt 1 or 2 shocks. This
      will be done to each hand over about 30 minutes total.

      A questionnaire about anxiety.

      Acoustic startle reflex test. Small electrodes will be stuck to the eye, hand, and leg.
      Sensors will be stuck to the palms. Small metal electrodes on the chest and inner arm will
      measure heart rate. Participants will wear headphones. Once everything is in place,
      participants will hear a low sound for about 10 minutes. They will hear a short louder sound
      every 45 60 seconds.
Objective

      The purpose of this protocol is to get adequate normal values to compare in clinical patient
      studies.

      Study population

      There will be two techniques developed in this study: Somatosensory Temporal Discrimination
      Threshold (STDT) and Acoustic Startle Reflex (ASR). For both studies we will collect data
      systematically in an adequate sample of normal subjects.

      We plan to recruit the following number of healthy volunteers (HV s) for each study.

      STDT: 50 HV

      ASR: 50 HV

      Design

      Subjects will come for up to 3 outpatient visits, during which they will participate in at
      least the STDT or the ASR. Before participation in any study, all participants will undergo
      screening for medical history and physical examination.

      For the STDT, the index finger in both hands will be stimulated.

      For the ASR, auditory stimulation will be administered at varying intervals. Subjects will
      also be asked to complete State Trait Anxiety Inventory (STAI) before participation in the
      study.

      Outcome measures

      STDT: discrimination threshold value

      ASR: EMG response from seven muscles, heart rate, and galvanic skin response
observational model: Cohort
time perspective: Prospective
measure: STDT values in both hands
time frame: throughout protocol
description: Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.
measure: The amount, latency and duration of muscle activity, heart rate, and skin conductance.
time frame: throughout protocol
description: Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.
arm group label: Healthy Volunteers
description: Healthy Volunteers between 18 and 68 years of age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 68 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Hallett, M.D.
role: Principal Investigator
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-N-0150.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor