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NCT04830163 | NOT YET RECRUITING | Stroke

Brain State-dependent PCMS in Chronic Stroke
Sponsor:

University of Texas at Austin

Brief 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.

Condition or disease

Stroke

Intervention/treatment

Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation
Actual Study Start Date : 2026-01-01
Estimated Primary Completion Date : 2030-07
Estimated Study Completion Date : 2031-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Brain State-dependent PCMS in Chronic Stroke

Location Details

NCT04830163

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Locations

Not yet recruiting

United States, Texas

University of Texas at Austin

Austin, Texas, United States, 78712