- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253718
Technical Development of Clinical Laboratory Studies
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.
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Volunteers
Healthy Volunteers between 18 and 68 years of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
STDT values in both hands
Time Frame: throughout protocol
|
Sub-study 1: Somatosensory Temporary Discrimination Threshold (STDT): STDT values in both hands.
|
throughout protocol
|
The amount, latency and duration of muscle activity, heart rate, and skin conductance.
Time Frame: throughout protocol
|
Sub-study 2: Acoustic Startle Reflex (ASR): The amount, latency and duration of muscle activity, heart rate, and skin conductance.
|
throughout protocol
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 170150
- 17-N-0150
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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