Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Last updated: May 12, 2025
Sponsor: Stanford University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Sham vibrotactile coordinated reset

Active Vibrotactile coordinated reset

Clinical Study ID

NCT05490277
65197
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age at the time of enrollment: 18-80 years

  2. Diagnosis of ischemic or hemorrhagic stroke

  3. Disease period of more than 6 months

  4. Mini Mental State Examination of at least 24 points

  5. No medications that affect balance

  6. Motor deficit

  7. Use of Motricity Arm and Leg index to include impaired individuals with somefunctioning

  8. Modified Rankin Scale for Neurologic Disability: Scores 3 or 4

Exclusion

Exclusion Criteria:

  1. Any significant psychiatric problems, including acute confusional state (delirium),ongoing psychosis, or clinically significant depression

  2. Any current drug or alcohol abuse

  3. History of recurrent or unprovoked seizures

  4. Any neurological disorder treatments that involve intracranial surgery or deviceimplantation

  5. Participation in another drug, device or biologic trial concurrently or within thepreceding days

  6. Pregnancy, breastfeeding or wanting to become pregnant during the trial

  7. History or presence of other major neurological or orthopedic diseases other thanstroke that limits motor functioning or cognitive ability

  8. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, orankle

  9. Botox, baclofen or any other treatment for spasticity except for bracing orsplinting within the previous 3 months

  10. Must be able to communicate with staff

  11. Severe sensory abnormalities of the fingers such as vibratory urticaria

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Sham vibrotactile coordinated reset
Phase:
Study Start date:
January 15, 2026
Estimated Completion Date:
November 15, 2028

Connect with a study center

  • Stanford University

    Stanford, California 94303
    United States

    Site Not Available

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