Not yet recruiting NCT05490277
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Vibrotactile coordinated reset, Sham vibrotactile coordinated reset.
- Who it may be relevant to
- Registry conditions: Chronic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Active Vibrotactile coordinated reset
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. - Device Sham vibrotactile coordinated reset
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.
Primary outcome measures
- Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months [Time frame: 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 [Time frame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
Secondary outcome measures (6)
- Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
- Vibratory temporal discrimination task [Time frame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT05490277 · 65197