Study Stopped
Investigator left the NIH.
Interhemispheric Interaction of Parieto-Motor Cortico-Cortical Plasticity
2 other identifiers
observational
N/A
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2017
CompletedFirst Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedNovember 20, 2018
November 1, 2018
1.2 years
August 17, 2017
November 19, 2018
Conditions
Keywords
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
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: 14677378BACKGROUNDBloom 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: 16211466BACKGROUNDArai 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
- PRINCIPAL INVESTIGATOR
Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
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