Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Stanford University

Status: Not yet enrolling

Conditions: Chronic Stroke

Treatments: Device: Sham vibrotactile coordinated reset; Device: Active Vibrotactile coordinated reset

Study type: Interventional

Funder types: Other

Identifiers

NCT05490277

65197

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Active Vibrotactile Coordinated Reset (vCR)

Active Comparator group

Description:

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.

Treatment:

Device: Active Vibrotactile coordinated reset

Sham Vibrotactile Coordinated Reset (vCR)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham vibrotactile coordinated reset