Clinical trial NCT05490277: Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
Official title: Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
Secondary outcomes:
measure: Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Sensorimotor reaction time task
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
measure: Vibratory temporal discrimination task
timeFrame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Peter A Tass, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: