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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive Brain Stimulation Modalities | Experimental | All participants will undergo three non-invasive brain stimulation modalities:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria:
Exclusion criteria
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.
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:
Concurrent enrollment in another interventional stroke recovery study.
Concerns that the subject cannot comply with study procedures and visits.
Pregnant individuals
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wuwei Feng, MD | Contact | 919 681 1700 | wayne.feng@duke.edu | |
| Megan N Gonzalez, MS | Contact | 9196687597 | megan.gonzalez@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wayne Feng, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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