Brain State-dependent PCMS in Chronic Stroke

Phase 1

Not yet recruiting

• Conditions: Stroke
• Interventions: Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

• Registration Number: NCT04830163
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Start: 2026-01-01
• Primary Completion: 2030-07
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCMS during random brain states	Brain state-dependent paired corticomotoneuronal stimulation (PCMS)	-
PCMS during brain states reflecting strong corticospinal transmission	Brain state-dependent paired corticomotoneuronal stimulation (PCMS)	-

Primary Outcome Measures

Name	Time	Method
Maximum hand force output	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	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 Outcome Measures

Name	Time	Method
Amplitude of motor evoked potentials	up to 1 hour after intervention	This will be measured as the peak-to-peak amplitude of motor-evoked potentials recorded from the stroke-affected first dorsal interosseous muscle
Time to complete the 9-hole peg test	up to 1 hour after intervention	This will be measured as the time needed to complete the task using the stroke-affected hand.

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States