Exploring how brain stimulation affects movement after stroke
Influence of Brain Oscillation-Dependent TMS on Motor Function
This study tests if a type of brain stimulation can help improve movement in people who have had a stroke and healthy adults by looking at how timing affects the results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03288220 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial magnetic stimulation (TMS) on motor function in both healthy adults and individuals who have experienced a stroke. Researchers aim to determine how the timing of brain stimulation correlates with brain oscillation phases to improve the consistency of TMS effects. Participants will undergo screening and TMS sessions to measure their brain's response to stimulation. The goal is to enhance rehabilitation strategies for stroke patients by understanding the relationship between brain activity and motor function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have had a stroke at least 6 months ago or healthy volunteers aged 50 and older.
Not a fit: Patients who are unable to voluntarily contract muscles in the affected arm or who had a stroke less than 6 months ago may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more effective rehabilitation techniques for stroke patients, improving their motor function.
How similar studies have performed: While TMS has been studied in various contexts, this specific approach of timing stimulation with brain oscillation phases is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Leonardo G Cohen, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Catherine L Blumhorst, C.R.N.P.
- Email: cathy.blumhorst@nih.gov
- Phone: (301) 451-1335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.