Technical Development of Clinical Laboratory Studies

Healthy Volunteers Clinical Trial

Official title: Technical Development of Clinical Laboratory Studies

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03253718
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Withdrawn
• Start date: May 25, 2021
• Completion date: May 25, 2021