Brain State-dependent PCMS in Chronic Stroke

This study is looking at a treatment called Brain state-dependent paired corticomotoneuronal stimulation (PCMS) for people who have difficulty using their hands after a stroke. PCMS combines brain stimulation (transcranial magnetic stimulation or TMS) and nerve stimulation (peripheral nerve stimulation or PNS) to strengthen the connections between your brain and muscles. Researchers want to see if delivering this stimulation at specific, optimal times works better than delivering it at random times to improve hand function. To join, you must have had a stroke more than 6 months ago, have some weakness in your arm and hand, and be able to give consent. The study will measure improvements in your maximum hand force and muscle activation up to one hour after the treatment. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 45 participants. It compares two ways of delivering combined brain and nerve stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, maximum hand force and muscle activation, are measured up to 1 hour after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04830163

Brain State-dependent PCMS in Chronic Stroke

Not Yet Recruiting
PHASE1Ages 18+InterventionalBasic science
University of Texas at Austin
~45 participants
Updated 2024-12-06 on ClinicalTrials.gov
What's tested:Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum hand force output
Measured over up to 1 hour after intervention
+1 more outcome measured
Stroke

NCT04830163

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas at Austin

    Austin, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

History of stroke \> 6 months ago
Presence of residual upper extremity hemiparesis
Willingness to participate
Ability to provide informed consent
Upper extremity Fugl-Meyer score \< 66
Mini Mental State Exam score \> 24
Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Exclusion

History of neurological disease other than stroke
Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
Mini Mental State Exam score \<= 24
No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere
  • Maximum hand force outputup to 1 hour after intervention

    This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions.

  • Maximum hand muscle activationup to 1 hour after intervention

    This will be measured using electromyography recordings of the stroke-affected first dorsal interosseous muscle during maximum voluntary contractions during pinching actions