The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.

NCT06765642 | Recruiting DMC FDA Device

• 1 other identifier: Pro00117160
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The study is about using a brain stimulation technique called rTMS (Repetitive Transcranial Magnetic Stimulation) to help improve hand muscles in people who had a stroke. Researchers want to understand how this device can help stroke patients use their hands better.

Conditions

Stroke; Stroke Patients; Arm Weakness as a Consequence of Stroke; Brain Stimulation; Transcranial Magnetic Stimulation Repetitive; Transcranial Magnetic Stimulation; Motor Learning; Chronic Stroke Patients; Chronic Stroke Survivors

Keywords

stroke; arm weakness; arm weakness as a consequence of stroke; stroke patients; transcranial magnetic stimulation; transcranial magnetic stimulation repetitive; motor learning; chronic stroke; chronic stroke patients; chronic stroke survivors

Outcome Measures

Primary Outcomes (1)

• To determine whether there is overall stimulation effect among three stimulation paradigms (FiTBS600; FiTBS2400; DiTBS2400) on the ipsilesional corticospinal excitability of a hand muscle.

  Each intervention session (total of 3) will consist of one format of iTBS stimulation. Before and after the intervention, single pulse TMS (spTMS) and motor sequence learning (MSL) will be used to assess the effect of the intervention on corticospinal excitability and motor performance.

  Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart)

Study Arms (1)

Non-invasive Brain Stimulation Modalities

EXPERIMENTAL

All participants will undergo three non-invasive brain stimulation modalities: 1. Focal conventional iTBS over the ipsilesional motor cortex (i.e., a single bout of 600 pulses over a single spot; FiTBS600). 2. Focal high dose iTBS over the ipsilesional motor cortex (i.e. 4 bouts of 600 pulses over a single spot = 2400 pulses; FiTBS2400). 3. Diffuse high dose iTBS over the ipsilesional motor cortex (i.e. 4 bouts of 600 pulses over 4 spots: 600 pulses/spot × 4 spots = 2400 pulses; DiTBS2400)

Diagnostic Test: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DIAGNOSTIC_TEST

The use of this approach aims to potentially maximize motor recovery in chronic stroke by harnessing corticospinal plasticity and modulating motor learning behavior.

Also known as: Repetitive Transcranial Magnetic Stimulation

Non-invasive Brain Stimulation Modalities

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=21 years old of any race or gender
• First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from stroke onset
• Unilateral arm weakness measured by FM-UM scale \<= 62/64
• Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject

You may not qualify if:

• Bilateral strokes (infarcts and/or hematoma)
• Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
• History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study.
• History of confirmed dementia or taking the following dementia drugs, such as Donepezil, Rivastigmine, Galantamine, Memantine, Aducanumab, Lecanemab, Donanemab that affecting their ability to follow study procedure.
• Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later).
• Presence of any MRI/rTMS risk factors including but not limited to:
• an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
• a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
• history of seizure disorder before stroke or seizure after stroke.
• preexisting scalp lesion or bone defect or hemicraniectomy.
• \. Concurrent enrollment in another interventional stroke recovery study. 7. Concerns that the subject cannot comply with study procedures and visits. 8. Pregnant individuals.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wayne Feng, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wuwei Feng, MD

CONTACT

919 681 1700; wayne.feng@duke.edu

Megan N Gonzalez, MS

CONTACT

9196687597; megan.gonzalez@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)