kTMP in Chronic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • kTMP sham stimulation 9 weeks + active stimulation 9 weeks

    Device

    kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation

  • kTMP 18 weeks

    Device

    Participants receive kTMP active stimulation for 18 weeks

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active TreatmentActive comparator 1 intervention
Group B: Crossover TreatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.

Secondary outcomes

1

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.

Time frame
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
2

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.

Time frame
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
3

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.

Time frame
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
4

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.

Time frame
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: