Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

NCT05490277 | Not Yet Recruiting FDA Device

• 1 other identifier: 65197
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (2)

• Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

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

  The Neuro quality of life upper extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better upper extremity abilities.

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

Secondary Outcomes (6)

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

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

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

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

• Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

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

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

• Sensorimotor reaction time task

  This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

Study Arms (2)

Active Vibrotactile Coordinated Reset (vCR)

ACTIVE COMPARATOR

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.

Device: Active Vibrotactile coordinated reset

Sham Vibrotactile Coordinated Reset (vCR)

SHAM COMPARATOR

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.

Device: Sham vibrotactile coordinated reset

Interventions

Active Vibrotactile coordinated reset DEVICE

Participants will receive active vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.

Active Vibrotactile Coordinated Reset (vCR)

Sham vibrotactile coordinated reset DEVICE

Participants will receive sham vibrotactile coordinated reset (vCR) which sends gentle vibrations to the fingertips at a specific pattern. The purpose of the intervention is to test the efficacy of active vCR in comparison to sham vCR.

Sham Vibrotactile Coordinated Reset (vCR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: 18-80 years
• Diagnosis of ischemic or hemorrhagic stroke
• Disease period of more than 6 months
• Mini Mental State Examination of at least 24 points
• No medications that affect balance
• Motor deficit
• Use of Motricity Arm and Leg index to include impaired individuals with some functioning
• Modified Rankin Scale for Neurologic Disability: Scores 3 or 4

You may not qualify if:

• Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
• Any current drug or alcohol abuse
• History of recurrent or unprovoked seizures
• Any neurological disorder treatments that involve intracranial surgery or device implantation
• Participation in another drug, device or biologic trial concurrently or within the preceding days
• Pregnancy, breastfeeding or wanting to become pregnant during the trial
• History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability
• More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle
• Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months
• Must be able to communicate with staff
• Severe sensory abnormalities of the fingers such as vibratory urticaria

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94303, United States

Location

Study Officials

• Peter A Tass, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yankulova

CONTACT

650-474-9547; jessky@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Director

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): November 15, 2028
• Last Updated: May 15, 2025

Record last verified: 2024-08

Locations

US (1)