Recruiting

TMS

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT03288220

Conditions

Healthy

Stroke

Normal Physiology

Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Healthy

Stroke

Normal Physiology

Aging

Study ID

NCT03288220

Start date

Sep 11, 2018

Status verified date

Aug 27, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

114 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers

Healthy volunteers age 18 and older

Stroke patients

Stroke patients aged 18 and older

Primary outcome measure

  • We will study if corticospinal excitability varies across different sensorimotor alpha EEG waveform oscillation phases in healthy older adults and chronic stroke patients with weakness in one or both arms. [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Catherine L Blumhorst, C.R.N.P.

(301) 451-1335cathy.blumhorst@nih.gov

Leonardo G Cohen, M.D.

(301) 496-9782cohenl1@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Aug 31, 2026

Last verified

Aug 27, 2026

Keywords

  • Stroke
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-08-31.