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| ID | Type | Description | Link |
|---|---|---|---|
| R44NS139730 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Active Comparator | Active treatment with kTMP for 18 weeks |
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| Crossover Treatment | Other | Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kTMP sham stimulation 9 weeks + active stimulation 9 weeks | Device | kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment | The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment. | Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34. |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | Measures timed functional tasks, strength testing, and analysis of movement quality when completing various upper extremity tasks. Uses a 6 point ordinal scale (0-5), where ) is does not attempt with the involved arm and 5 is arm does participate and movement appears normal. Maximum score of 75. Lower scores indicate lower functional levels. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karunesh Ganguly, MD, PhD | Contact | 415-514-1252 | karunesh.ganguly@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karunesh Ganguly, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| kTMP 18 weeks | Device | Participants receive kTMP active stimulation for 18 weeks |
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| Stroke Impact Scale | Self reported questionnaire that evaluates disability and health related quality of life after stroke, consisting of 59 items, assessing strength, hand function, ADL/iADL, mobility, communication, emotion, memory and thinking, participation/role function. Each item is rated in a 5 point Likert scale, where 1 equals could not do it at all and 5 equals not difficult at all. Score ranges 0-100. Higher score indicates less disability and high quality of life after stroke. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| Stroke Specific QOL | Questionnaire consisting of 49 items in the 12 domains of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality. Each item is assessed on a 5 point Guttman type scale, where 1=total help; couldn't do it at all; strongly agree and 5 =no help needed; no trouble at all; strongly disagree. Higher scores indicate better functioning. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| EuroQOL | A health questionnaire that measures 5 dimensions including mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each item is described by 3 levels of problems, where 1=none, 2=mild to moderate, and 3=severe. This provides a simple single index value for health status, where a higher score indicates worse health state. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| Motor Activity Log | Self reported perception of Quality of movement are rated in 30 functional tasks, scored on a 6 point ordinal scale where 0=weaker arm not used at all for that activity and 5=ability to use the weaker arm for that activity is as good as before the stroke(normal). A higher score indicates better quality upper extremity movement. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| Modified Ashworth Scale Scores | Test of resistance to passive movement about a joint, scores range from 0 to 5 where 0=no increase in muscle tone and 5=affected part(s) rigid. Hight scores indicate greater muscle tone. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| Action Research Arm Test | Measures performance of the upper extremity in grasp, grip, pinch, and gross arm movements, rated on a 4 point ordinal scale where 3=performs test normally and 0=can perform no part of test. Higher score indicates greater function of the upper extremity. | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |