kTMP for Arm Rehabilitation in Chronic Stroke Patients
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
Recruiting
N/AInterventional Study
StrokeChronic Stroke PatientsArm Weakness as a Consequence of Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Magnetic Tides · Industry
Who this trial is looking for
This trial is looking for adults aged 18-80 who have had a stroke at least a year ago. Participants will use a special treatment to help improve arm and hand movement.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I had a stroke more than 12 months ago.
I can follow two-step commands.
I have an upper limb Fugl-Meyer score between 20 and 50.
I can communicate and give consent.
I have motor evoked potentials when my brain is stimulated.
You may not be able to join if
I have moderate or severe cognitive impairment.
I have severe apraxia.
I have a serious uncontrolled medical condition.
I am pregnant or planning to become pregnant.
I had botulinum toxin injections in my arm in the last 3 months.
I have severe spasticity in my affected arm.
I have metal implants in my head.
I had a seizure in the last 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 co…
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
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