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Recruiting NCT07631078

kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot

Conditions: Stroke, Chronic Stroke Patients, Arm Weakness as a Consequence of Stroke

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Magnetic Tides

Location: Magnetic Tides, Inc. Berkeley California

Summary

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

Inclusion criteria: 1. Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment. 2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50. 3. Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands. 4. Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive). Exclusion criteria: 1. Participants with moderate or severe cognitive impairment (MoCA \< 18). 2. Participants with sensory deficits FMA-S \< 6/12 (with proprioception \< 4/8). 3. Participants with severe apraxia (TULIA \< 5). 4. Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent. 5. Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease. 6. Pregnancy or plans to become pregnant during the study period. 7. Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study. 8. Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4). 9. Absolute contraindications related to non-invasive brain stimulation, including: 9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07631078). StuddyBuddy aggregates publicly available trial information.