kTMP-Enhanced Arm Rehabilitation in Chronic Stroke (KULMINATE) Pilot

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 6-week, double-blind, randomized, sham-controlled pilot study. Participants with chronic stroke who have moderate arm weakness will be assigned to either kTMP plus simple motor tasks or sham kTMP with the same tasks. The study measures upper-limb movement outcomes at the end of treatment and during follow-up up to 6 months. Randomization occurs within one week of starting treatment, with sessions delivered three times per week. Outcomes include kinematic measures such as range of motion in the arm, hand, and fingers.

Why it matters

Who can join: the full rules

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 (MMSE \< 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

Where it's running

• UCSF Mission Bay- Sandler Neurosciences Center
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Ludovica Labruna, PhD
• Email: participate@magnetictides.com
• Phone: 5104237125

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intermittent Theta Burst Stimulation (iTBS) to improve upper‑limb movement after chronic stroke

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• Intermittent Theta Burst Stimulation for lower limb recovery after chronic stroke

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• Digital rehabilitation system for stroke recovery

  This study is testing a smartphone app that uses virtual and augmented reality to help stroke patients recover at home and see if it works better than regular therapy.

  Recruiting at 2 sites Eodyne Systems SL · Cluj-Napoca and 1 other locations · NCT06885502

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.