Not Yet RecruitingPhase 1/2

Brain State-dependent PCMS in Chronic Stroke

United States45 participantsStarted 2026-01-01

Plain-language summary

After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Maximum hand force output

Timeframe: up to 1 hour after intervention

Maximum hand muscle activation

Timeframe: up to 1 hour after intervention

Trial details

NCT IDNCT04830163

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07