Clinical trial NCT06765642: The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.
Official title: Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To determine whether there is overall stimulation effect among three stimulation paradigms (FiTBS600; FiTBS2400; DiTBS2400) on the ipsilesional corticospinal excitability of a hand muscle.
timeFrame: Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wuwei Feng, MD
role: PRINCIPAL_INVESTIGATOR
References: