Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Launched by STANFORD UNIVERSITY · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Vibrotactile Coordinated Reset stimulation (vCR) to help people recover motor abilities after a stroke. The treatment is given using a special device called the Vibrotactile Brain Glove. The goal is to see if this non-invasive therapy can improve movement in patients who have had a stroke for more than six months. To ensure accurate results, the study will also include a group of participants receiving a sham treatment, which means they won’t actually be getting the vCR therapy but will be monitored in the same way.

To be eligible for the trial, participants need to be between 18 and 80 years old and must have experienced either an ischemic or hemorrhagic stroke. They should have some motor difficulties but still be able to function at a basic level. Participants will undergo assessments to ensure they meet specific criteria, such as having a Mini Mental State Examination score of at least 24, which indicates reasonable cognitive function. During the study, participants can expect to wear the Vibrotactile Brain Glove and receive regular evaluations to track their progress. It’s important to note that certain health conditions or treatments may exclude someone from participating, so potential volunteers should discuss their medical history with the study team.

Gender

ALL

Eligibility criteria

• 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 some functioning
• • 8. Modified Rankin Scale for Neurologic Disability: Scores 3 or 4
• 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 device implantation
• • 5. Participation in another drug, device or biologic trial concurrently or within the preceding days
• • 6. Pregnancy, breastfeeding or wanting to become pregnant during the trial
• • 7. History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability
• • 8. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle
• • 9. Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months
• • 10. Must be able to communicate with staff
• • 11. Severe sensory abnormalities of the fingers such as vibratory urticaria