NCT03288220 Influence of Brain Oscillation-Dependent TMS on Motor Function
| NCT ID | NCT03288220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 114 participants |
| Start Date | 2018-09-11 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 114 participants in total. It began in 2018-09-11 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: When people have a stroke, they often have difficulty moving their arms and hands. Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke can move their arms and hands. But the effects of TMS are minor, and it doesn t work for everyone. Researchers want to study how to time brain stimulation so that the effects are more consistent. Objective: To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved. Eligibility: Adults ages 18 and older who had a stroke at least 6 months ago Healthy volunteers ages 50 and older Design: Participants will have up to 5 visits. At visit 1, participants will be screened with medical history and physical exam. Participants with stroke will also have TMS and surface electromyography (sEMG). For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple movements during TMS. For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded. At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noise. At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG, small electrodes on the scalp will record brainwaves. Participants will sit still, watch a movie, or do TMS. Participants may be asked to have 2 extra visits to redo procedures.
Eligibility Criteria
* INCLUSION CRITERIA: * Healthy younger adults: * Ages 18 years to less than 50 years. (18 to 49) * Willingness/ability to provide informed consent. * Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening. * Healthy older adults: * Age 50 and over * Willingness/ability to provide informed consent. * Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening. * Stroke patients: * Age 18 and over. * Unilateral or bilateral upper limb paresis with the ability to voluntarily contract a finger, hand, wrist, or elbow muscle in the affected arm(s). * Stroke onset \> 6 months prior to participation. * Intact M1 sufficient to induce motor evoked potentials in the affected upper extremity following ipsilesional TMS, as evaluated during the TMS Screening. * Willingness/ability to provide informed consent. * If the investigator feels the individual s capacity to provide informed consent is questionable, the NIH Human Subjects Protection Unit (HSPU) will be requested to determine the individual s ability to consent. EXCLUSION CRITERIA: * Healthy younger and older adults: * Presence of severe neurological or medical disorder (e.g., Parkinson s disease or multiple sclerosis). * History of seizures. * Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), tri-cyclic or other anti-depressants, benzodiazepines, or prescription stimulants. * TMS contraindications, such as: * Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull. * Diagnosed severe hearing loss. * Current pregnancy. * Staff from our section. * Stroke patients: * Presence of severe neurological or medical disorder, other than stroke (e.g., Parkinson s disease or multiple sclerosis). * History of brainstem stroke. * History of seizures. * Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), benzodiazepines, or prescription stimulants. * TMS contraindications, such as: * Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull. ---Diagnosed severe hearing loss. * Current pregnancy. * Staff from our section.
Contact & Investigator
Leonardo G Cohen, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT03288220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03288220 currently recruiting?
Yes, NCT03288220 is actively recruiting participants. Contact the research team at cathy.blumhorst@nih.gov for enrollment information.
Where is the NCT03288220 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03288220 clinical trial?
NCT03288220 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Leonardo G Cohen, M.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 114 participants.