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

NCT ID: NCT06765642

Last Updated: 2025-07-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2027-04-30

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.

Detailed Description

The goal of this study is to determine the efficacy of a high-dose of a excitatory-specific patterned Transcranial Magnetic Stimulation (i.e., intermittent theta-burst stimulation - iTBS) protocol as a neuromodulatory tool on the neuromotor recovery (corticospinal excitability and motor performance) in individuals with chronic stroke using either the conventional iTBS protocol (600 pulses; iTBS600) or a high dose iTBS protocols (a total of 2400 pulses) over a single spot (Focal iTBS; FiTBS2400) and 4 spots (Diffuse iTBS: DiTBS2400) on the ipsilesional hemisphere. The use of this approach aims to potentially maximize motor recovery in chronic stroke by harnessing corticospinal plasticity and modulating motor learning behavior.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-invasive Brain Stimulation Modalities

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)

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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.

Interventions

Transcranial Magnetic Stimulation

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

Inclusion Criteria

1. Age >=21 years old of any race or gender

2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from stroke onset

3. Unilateral arm weakness measured by FM-UM scale <= 62/64

4. Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject

Exclusion Criteria

1. Bilateral strokes (infarcts and/or hematoma)

2. Other co-existent neuromuscular disorders affecting upper extremity motor impairment.

3. 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.

4. 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.

5. 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).

6. Presence of any MRI/rTMS risk factors including but not limited to:

1. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.

2. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.

3. history of seizure disorder before stroke or seizure after stroke.

4. preexisting scalp lesion or bone defect or hemicraniectomy.

6. Concurrent enrollment in another interventional stroke recovery study. 7. Concerns that the subject cannot comply with study procedures and visits. 8. Pregnant individuals.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wuwei Feng, MD

Role: CONTACT

wayne.feng@duke.edu

919 681 1700

Megan N Gonzalez, MS

Role: CONTACT

megan.gonzalez@duke.edu

9196687597

Facility Contacts

Wayne Feng, MD

Role: primary

wayne.feng@duke.edu

919 681 1700

Other Identifiers

Pro00117160

Identifier Type: -

Identifier Source: org_study_id