Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active Vibrotactile coordinated reset

    Device

    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.

  • Sham vibrotactile coordinated reset

    Device

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Active Vibrotactile Coordinated Reset (vCR)Active comparator 1 intervention
Group B: Sham Vibrotactile Coordinated Reset (vCR)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

Time frame
This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
2

Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months

The Neuro quality of life upper extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better upper extremity abilities.

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 outcomes

1

Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months

The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Functional categories may be scored from 0 to 1, 0 to 2, or 0 to 3, depending on the item. Total scores range from 0 to 20, with lower scores indicating increased disability

Time frame
This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
2

Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months

The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations.Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement). Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.

Time frame
This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
3

Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months

This test is a measure walking ability with correlates to balance and fall risk. The patient is timed using a stopwatch and the patient is instructed to walk as quickly as possible for 3 meters. The test is scored as such: ≤ 10 seconds = normal ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid ≤ 30 seconds = problems, cannot go outside alone, requires gait aid \* A score of ≥ 14 seconds has been shown to indicate high risk of falls

Time frame
This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
4

Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months

The Neuro quality of life lower extremity short form test measures the functionality of upper extremities. This is a self-report questionnaire that has a Likert scale from 1 to 5, with 5 indicating no difficulties and 1 indicating unable to do. Total possible points are out of 40, with a higher score indicating better lower extremity abilities.

Time frame
This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit

Other outcomes

Sponsors and contacts

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