NCT03253731

Brief Summary

Background: The two hemispheres of the brain are connected. Changes in one hemisphere affect the other through this connection. Research has shown that training new skills in one hand improves the same skills for the other hand. Researchers want to learn more about how the brain works to transfer the skills to the other hand. Objective: To learn how changes on one side of the brain affect the other side. To study the activity of the left and right sides of the brain in healthy adults. Eligibility: Healthy volunteers ages 18-55 years old who are right-handed. Design: Participants will be screened with a medical history and physical exam. They will complete a questionnaire about their handedness. This may be done on paper or on a computer. Participants may have urine pregnancy tests. Participants will have 2 study visits. Participants will have a structural magnetic resonance imaging (MRI) scan. MRI uses a strong magnetic field and radio waves to take pictures of the brain. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will have transcranial magnetic stimulation (TMS). Two wire coils will be placed on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that affects brain activity. Participants may be asked to tense certain muscles or do simple tasks during TMS. Participants will have electromyography. Small sticky pad electrodes will be attached to the skin on the hands. Muscle activity will be recorded during the TMS procedure.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

August 17, 2017

Last Update Submit

November 19, 2018

Conditions

Keywords

Brain PlasticityHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • MEP amplitude at S50 over each side of M1 with respect to time (before, and immediately after and 30-45 min after cc-PAS over the left M1).

    3 timepoints

Study Arms (1)

Healthy Volunteers

15 healthy volunteers

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • Between the age of 18 and 55 years
  • Right-handed
  • English speaking
  • Ability to give informed consent

You may not qualify if:

  • Illegal drugs use within the past 6 months based on history alone
  • Abnormal findings on neurologic examination
  • Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
  • History of or current brain tumor, stroke, head trauma with loss of consciousness \>few seconds, epilepsy or seizures
  • History of or current episode of major depression or any major psychiatric illness (axis I disorders)
  • Current diagnosis of neurologic disorder
  • Presence of pacemaker, intracardiac lines, implanted pumps or stimulators, or metal objects inside the eye or skull. Dental fillings and dental braces are allowed.
  • Open scalp wounds or scalp infection
  • Employees and/or staff of HMCS/NINDS
  • Taking benzodiazepines at the time of the entire study or within 12 days prior to the study. NOTE: Medication will not be stopped or held for participation in this study.
  • Taking, at the time of the entire study or within 2 weeks prior to the study, any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, amphetamines, ketamine, gamma-hydroxybutyrate (GHB), theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporine, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, antihistamines, and sympathomimetics. NOTE: Medication will not be stopped or help for participation in this study.
  • Being pregnant
  • You may not be eligible to have MRI or TMS in this study if:
  • You have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may have small metal fragments in the eye.
  • You are uncomfortable in small closed spaces (you have claustrophobia) so that you would feel uncomfortable in the MRI machine.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Awiszus F. TMS and threshold hunting. Suppl Clin Neurophysiol. 2003;56:13-23. doi: 10.1016/s1567-424x(09)70205-3. No abstract available.

    PMID: 14677378BACKGROUND
  • Bloom JS, Hynd GW. The role of the corpus callosum in interhemispheric transfer of information: excitation or inhibition? Neuropsychol Rev. 2005 Jun;15(2):59-71. doi: 10.1007/s11065-005-6252-y.

    PMID: 16211466BACKGROUND
  • Arai N, Muller-Dahlhaus F, Murakami T, Bliem B, Lu MK, Ugawa Y, Ziemann U. State-dependent and timing-dependent bidirectional associative plasticity in the human SMA-M1 network. J Neurosci. 2011 Oct 26;31(43):15376-83. doi: 10.1523/JNEUROSCI.2271-11.2011.

    PMID: 22031883BACKGROUND

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR
0

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

August 11, 2017

Primary Completion

November 9, 2018

Study Completion

November 9, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11