kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMagnetic Tides
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 aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Disqualifiers
Participants with moderate or severe cognitive impairment (MMSE < 18).
Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
Participants with severe apraxia (TULIA < 5).
Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
kTMP
DeviceA new non-invasive brain stimulation tool
Sham kTMP
DeviceA new non-invasive brain stimulation tool with sham setting selected
Treatment groups
6 Participants
are divided into 2 treatment groupsGroup A: Active kTMPExperimental treatment 1 intervention
Group B: Sham kTMPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Movement Quality Index (MQI)
Kinematic data will be captured using a markerless, three-camera motion tracking system during a standardized reach-to-grasp task, with 30 trials per assessment. The cameras will reconstruct 3D hand, arm, and shoulder motion. The primary outcome is change from baseline in the Movement Quality Index (MQI), compared between kTMP and sham groups. MQI is a composite kinematic score calculated as range of motion (ROM) divided by trial-to-trial variability (T2TV), both derived from the 3D reconstructions: ROM: range, speed, and smoothness of hand/arm motion, including elbow and shoulder joint angles. T2TV: consistency across trials, measured as variance of 3D trajectories around the mean trajectory.
Time frame
Enrollment, then weeks 4, 6, 10, 18, 30Secondary outcomes
1
Fugl- Meyer Assessment (Upper Extremity) FMA-UE
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 4, 6, 10, 18, 302
Modified Ashworth Scale (MAS)
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.
Time frame
Enrollment, then weeks 4, 6, 10, 18, 303
Stroke Impact Scale (SIS)
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
Enrollment, then weeks 4, 6, 10, 18, 304
EuroQOL (EQ-5D)
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
Enrollment, then weeks 4, 6, 10, 18, 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Magnetic Tides
Lead sponsor
University of California, San Francisco
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov