Arm Weakness as a Consequence of Stroke, Brain Stimulation, Chronic Stroke Patients, Chronic Stroke Survivors, Motor Learning, Stroke, Stroke Patients, Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Repetitive
Conditions
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
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.
Interventions
DIAGNOSTIC_TESTTranscranial 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=21 years old of any race or gender 2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset 3. Unilateral arm weakness measured by FM-UM scale \<= 62 out of 66 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. 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). 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether there is overall stimulation effect among three stimulation paradigms (FiTBS600; FiTBS2400; DiTBS2400) on the ipsilesional corticospinal excitability of a hand muscle. | Baseline, prior to and after intervention (Pre0 and Pre1; 45 minutes apart) | 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. |
Countries
United States
Contacts
CONTACTWuwei Feng, MD
CONTACTMegan N Gonzalez, MS
PRINCIPAL_INVESTIGATORWayne Feng, MD
Duke University
Outcome results
None listed