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Technical Development of Clinical Laboratory Studies

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Withdrawn
CT.gov ID
NCT03253718
Collaborator
(none)
0
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Technical Development of Clinical Laboratory Studies
    Actual Study Start Date :
    May 25, 2021
    Actual Primary Completion Date :
    May 25, 2021
    Actual Study Completion Date :
    May 25, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy Volunteers

    Healthy Volunteers between 18 and 68 years of age

    Outcome Measures

    Primary Outcome Measures

    1. STDT values in both hands [throughout protocol]

      Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.

    2. The amount, latency and duration of muscle activity, heart rate, and skin conductance. [throughout protocol]

      Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 68 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    • INCLUSION CRITERIA:

    • Between 18 and 68 years of age

    • Ability to give informed consent

    • Able to understand the procedures and requirements of the study

    EXCLUSION CRITERIA:

    • Diagnosis of a neurological disorder

    • Illegal drug use within the past six months. The intent is to exclude those with drug use that may affect study results

    • Self-reported consumption of >7 alcoholic drinks a week for women and >14 alcoholic drinks a week for men

    • Unwillingness to abstain from caffeine or alcohol on the day of the study

    • Abnormal findings on neurological exam of clinical significance

    • History of or current brain tumor, stroke, head trauma with loss of consciousness > few seconds, epilepsy or seizures

    • Open scalp wounds or scalp infections

    • For ASR, unwillingness to abstain from the use of cigarettes on the day of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Mark Hallett, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Neurological Disorders and Stroke (NINDS)
    ClinicalTrials.gov Identifier:
    NCT03253718
    Other Study ID Numbers:
    • 170150
    • 17-N-0150
    First Posted:
    Aug 18, 2017
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS)
    Healthy Volunteers

    Study Results

    No Results Posted as of May 27, 2021