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Clinical Trials/NCT04830163
NCT04830163
Not Yet Recruiting
Phase 1

Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation

University of Texas at Austin1 site in 1 country45 target enrollmentJanuary 1, 2026
ConditionsStroke

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Texas at Austin
Enrollment
45
Locations
1
Primary Endpoint
Maximum hand force output
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2026
End Date
July 2031
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Maximum hand force output

Time Frame: up 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 activation

Time Frame: up 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

Secondary Outcomes

  • Amplitude of motor evoked potentials(up to 1 hour after intervention)
  • Time to complete the 9-hole peg test(up to 1 hour after intervention)

Study Sites (1)

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