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Behavioural Intervention

Vibrotactile Therapy for Stroke

N/A

Waitlist Available

Led By Peter A Tass, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

Awards & highlights

Study Summary

This trialstudies the effects of a non-invasive therapy, vCR, on recovery from stroke. The therapy is administered with a device called the VT Brain Glove. A sham treatment is also included to measure the true effects of vCR.

Who is the study for?

This trial is for adults aged 18-80 who've had a stroke at least 6 months ago, have some motor function left, and can mentally engage (score of ≥24 on a mental state exam). They shouldn't be on balance-affecting meds or have other major neurological issues, severe joint stiffness, recent spasticity treatments except bracing/splinting, or be pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests Vibrotactile Coordinated Reset (vCR) therapy using the VT Brain Glove to improve motor skills in chronic stroke patients. Participants will receive either active vCR or a sham treatment without therapeutic effect to compare outcomes.See study design

What are the potential side effects?

Since vCR is non-invasive and uses tactile stimulation through a glove device, side effects are expected to be minimal. However, participants may experience discomfort or skin irritation from the glove.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and this clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebrovascular accident

Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months

Secondary outcome measures

Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months

Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months

Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Vibrotactile Coordinated Reset (vCR)Active Control1 Intervention

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.

Group II: Sham Vibrotactile Coordinated Reset (vCR)Placebo Group1 Intervention

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,388 Previous Clinical Trials

17,334,396 Total Patients Enrolled

25 Trials studying Stroke

56,437 Patients Enrolled for Stroke

Peter A Tass, MD, PhDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Vibrotactile Coordinated Reset (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05490277 — N/A

Stroke Research Study Groups: Active Vibrotactile Coordinated Reset (vCR), Sham Vibrotactile Coordinated Reset (vCR)

Stroke Clinical Trial 2023: Vibrotactile Coordinated Reset Highlights & Side Effects. Trial Name: NCT05490277 — N/A

Vibrotactile Coordinated Reset (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490277 — N/A

Frequently Asked Questions

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

Are there opportunities for potential participants to join this investigation?

"Clinicaltrials.gov data confirms that this research is no longer taking on participants; the trial was initially posted on December 1, 2022 and last edited October 24th of the same year. However, there are presently 1045 other trials actively recruiting patients."

Answered by AI

Are participants aged 50 or older eligible for this trial?

"According to the study's criteria, potential participants must be at least 18 and not exceed 80 years of age."

Answered by AI

Am I able to become involved in this research project?

"This medical investigation is accepting enrolment from patients aged 18 to 80 that have had a stroke for at least 6 months and present with no less than 24 points on the Mini Mental State Examination. Furthermore, they must not be taking medications which affect balance and their motor deficits should be indicated by scores 3 or 4 on the Modified Rankin Scale of Neurologic Disability. In addition, the Motricity Arm & Leg Index will validate whether individuals possess some functioning."

Answered by AI

What goals is this clinical trial striving to accomplish?

"The primary aim of this clinical trial, which will be monitored at baseline visit, three month visit, four month visit, seven month visit and eight month visit is to assess the Neuro Quality of Life Upper Extremity Short Form test scores from each interval. Secondary objectives include ascertaining Action Research Arm Test performance (a 19-item observational measure that grades upper extremities on a 4-point scale), assessing Neuro Quality of Life Lower Extremity Short Form results (0–40 points; higher score indicating better lower limb abilities) and Timed Up and Go tests (≤ 10 seconds indicates normal mobility)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Peter Tass, MD, PhD 2024. "Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05490277.