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
Qualifiers
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 (MoCA < 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
Treatments tested in this trial
- kTMP
- Sham kTMP
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Magnetic Tides
Lead sponsor
University of California, San Francisco
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov