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

Duke University

Status: Enrolling

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

Treatments: Diagnostic Test: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06765642

Pro00117160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Non-invasive Brain Stimulation Modalities

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Transcranial Magnetic Stimulation