Status:
NOT_YET_RECRUITING
Brain State-dependent PCMS in Chronic Stroke
Lead Sponsor:
University of Texas at Austin
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 combine...
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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04830163
Start Date
January 1 2026
End Date
July 1 2031
Last Update
December 6 2024
Active Locations (1)
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1
University of Texas at Austin
Austin, Texas, United States, 78712