Influence of Brain Oscillation-Dependent TMS on Motor Function

NCT03288220 | Recruiting

• 2 other identifiers: 17016817-N-0168
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  For both experiments, the primary outcome measure is corticospinal excitability. Exploratory outcome measures include MEP amplitude variability, and TMS-induced oscillations

  6 years

Study Arms (2)

Healthy volunteers

Healthy volunteers age 18 and older

Stroke patients

Stroke patients aged 18 and older

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experiment 1: Up to 24 older healthy volunteers (ages 50 and older). Experiment 2 (added in October 2023): Up to 31 young healthy adults (18-49) and 31 older healthy adults (50 and older). Experiment 3: Up to 28 stroke patients (age 18 and older). Total: up to 114 participants.

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Leonardo G Cohen, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 20, 2017
• Study Start: September 11, 2018
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07-09

Locations

US (1)