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Brain Stimulation

Brain State-Dependent PCMS for Stroke Recovery

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of residual upper extremity hemiparesis
Upper extremity Fugl-Meyer score < 66
Must not have
No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere
History of neurological disease other than stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour after intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether specific time windows for combined brain and nerve stimulation are more effective than random time windows in improving post-stroke hand function.

Who is the study for?
This trial is for individuals who have had a stroke at least 6 months ago and now struggle with hand function due to upper extremity hemiparesis. They must be mentally fit (with a Mini Mental State Exam score over 24), willing to participate, able to consent, and have some movement in their affected arm but not full recovery (Fugl-Meyer score under 66).
What is being tested?
The study tests whether delivering paired corticomotoneuronal stimulation (PCMS) during specific brain states improves hand function after stroke compared to random timing of PCMS. It aims to strengthen the neural pathways that control the hand by using combined brain and nerve stimulation.
What are the potential side effects?
While side effects are not explicitly listed, potential risks may include discomfort or mild pain from nerve stimulation, headache or scalp discomfort from TMS, and possible temporary worsening of motor symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have weakness in one of my arms.
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My arm and hand movement is limited.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My brain does not respond normally to a specific type of brain scan.
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I have a neurological condition, but it's not a stroke.
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My arm and hand movements are fully functional.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 hour after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum hand force output
Maximum hand muscle activation
Secondary study objectives
Amplitude of motor evoked potentials
Time to complete the 9-hole peg test

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PCMS during brain states reflecting strong corticospinal transmissionExperimental Treatment1 Intervention
Group II: PCMS during random brain statesActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
378 Previous Clinical Trials
86,560 Total Patients Enrolled
10 Trials studying Stroke
1,058 Patients Enrolled for Stroke

Media Library

Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS) (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04830163 — Phase 1 & 2
Stroke Research Study Groups: PCMS during brain states reflecting strong corticospinal transmission, PCMS during random brain states
Stroke Clinical Trial 2023: Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS) Highlights & Side Effects. Trial Name: NCT04830163 — Phase 1 & 2
Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS) (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04830163 — Phase 1 & 2
~30 spots leftby Jul 2030
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