Technical Development of Clinical Laboratory Studies

NCT03253718 | Withdrawn

• 2 other identifiers: 17015017-N-0150
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• STDT values in both hands

  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.

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

  throughout protocol

Study Arms (1)

Healthy Volunteers

Healthy Volunteers between 18 and 68 years of age

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HV s will be recruited through NIH Patient Recruitment and Public Liaison Office and from our database of individuals who have participated in prior studies and are interested in being contacted for additional studies.

You may qualify if:

• Between 18 and 68 years of age
• Ability to give informed consent
• Able to understand the procedures and requirements of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 18, 2017
• Study Start: May 25, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

US (1)