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Brain Stimulation

Brain State-Dependent PCMS for Stroke Recovery

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour after intervention
Awards & highlights

Study 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).Check my eligibility
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.See study design
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
Select...
I have weakness in one of my arms.
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My arm and hand movement is limited.

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

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

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
353 Previous Clinical Trials
81,199 Total Patients Enrolled
8 Trials studying Stroke
841 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are being recruited for this investigation?

"That is accurate. The clinical trial in question, which was first announced on June 1st, 2022, remains open and actively recruiting patients. So far, 45 individuals have been recruited from a single site."

Answered by AI

Are there any enrollments still available for this research project?

"Yes, this clinical trial is still recruiting patients as of today. The listing was first posted on June 1st, 2022 and has been updated as recently as yesterday."

Answered by AI
~4 spots leftby Jul 2024