About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults age 18-80 years old who have had a stroke resulting in hemiplegia
Ability to communicate, understand, and give appropriate consent
Other criteria may apply
Disqualifiers
Significant cognitive impairment
inability to adhere to the study protocol or provide informed consent
pregnancy
additional criteria may apply
Trial design
Crossover
Treatments tested in this trial
kTMP sham stimulation 9 weeks + active stimulation 9 weeks
DevicekTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation
kTMP 18 weeks
DeviceParticipants receive kTMP active stimulation for 18 weeks
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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