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Neurophysiology of Surround Inhibition in the Human Motor Cortex

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ClinicalTrials.gov Identifier: NCT03018262
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

Movement disorders have many different causes and symptoms. Researchers still do not fully understand which parts of the brain are involved in fine movement. They want to learn about which brain regions could be abnormal in people with movement disorders.

Objective:

To better understand how the brain controls movement.

Eligibility:

Healthy, right-handed adults age 18-70 years old.

Design:

Participants will be screened with a physical exam and questions about their handedness. They may have a urine test.

Participants will have 1 or 2 clinic visits. The first visit will last about 1.5 hours. The second will last about 3 hours.

Participants will have structural magnetic resonance imaging (MRI). A strong magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides in and out of a metal cylinder.

Participants may have transcranial magnetic stimulation. A wire coil is held on the scalp. A brief electrical current is passed through the coil and creates a magnetic pulse that stimulates the brain. Participants will wear a pair of glasses or a headband with small sensors so researchers can track head position.

Participants will perform a simple index finger movement task.

Participants may have surface electromyography from at least two hand muscles. Small metal disk or adhesive pad electrodes will be taped to the skin. Participants will be seated in a comfortable chair with their hands placed on a pillow.

Participants may have an electroencephalography. A cap with small disc electrodes will be placed on the scalp....


Condition or disease
Normal Physiology

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detailed Evaluation of the Neurophysiology of Surround Inhibition in the Human Motor Cortex
Study Start Date : January 11, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort
Healthy Volunteers
Healthy volunteers age between 18-70 years



Primary Outcome Measures :
  1. latency and amplitude of the different components of the TMS-evoked potentials [ Time Frame: throughout protocol ]
    Sub-study 1: latency and amplitude of the different components of the TMS- evoked potentials.

  2. Amplitude of the MEP in the EMG signal elicited by single/paired pulse TMS at rest or movement onset will give information about the corticospinal excitability. [ Time Frame: throughout protocol ]
    Sub-study 2: TMS: The amplitude of the motor evoked potential (MEP) in the EMG signal elicited by single/paired pulse TMS at rest or movement onset will give information about the corticospinal excitability.

  3. Amplitude of the motor evoked potential (MEP) in the EMG signal elicited by single pulse TMS at rest or during a motor task will give information about the corticospinal excitability. [ Time Frame: throughout protocol ]
    Sub-study 3:TMS: The amplitude of the motor evoked potential (MEP) in the EMG signal elicited by single pulse TMS at rest or during a motor task will give information about the corticospinal excitability.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HVs will be recruited from our database of individuals who have participated in prior studies and are interested in being contacted for additional studies.@@@@@@
Criteria
  • INCLUSION CRITERIA:
  • Age between 18 - 70 years.
  • Right-handed (tested by the Edinburg handedness inventory).
  • Able to give informed consent.
  • Able to comply with all study procedures.
  • Abstain from alcohol for at least 48 hrs prior to the study and caffeine on the day of the study (based on oral interview).

EXCLUSION CRITERIA:

  • Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
  • Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
  • Abnormal findings on neurological examination.
  • History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
  • Current episode of major depression or any major psychiatric illness.
  • Taking medications that act directly on the central nervous system such as anti-epileptics, anti-histamines, anti-parkinsonian medication, muscle relaxants, medication for insomnia, anti-depressants, anti-anxiety medication.
  • Presence of any metal in the eye or skull area such as a brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
  • Presence of pacemaker, intracardiac lines, implanted pumps or stimulators or metal objects inside the eye or skull.
  • Known hearing loss.
  • NIH employees and/or staff.
  • Pregnancy

EXCLUSION CRITERIA for MRI (sub-study 2 only):

We will follow the Clinical Radiology/NMR Center guidelines for MR safety.

Some of the exclusions are:

  • Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
  • Have metallic dental fillings which are likely to cause MRI artifacts
  • Unable to lie flat on the back for the expected length of the experiment,
  • up to 30 mins.
  • Uncomfortable being in a small space for the expected length of the experiment, up to 30 mins.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018262


Contacts
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Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03018262     History of Changes
Other Study ID Numbers: 170031
17-N-0031
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: July 25, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Surround Inhibition
Motor Control
Transcranial Magnetic Stimulation (TMS)
TMS-Evoked Potential