Back to resultsVibrotactile Coordinated Reset for the Treatment of Chronic Stroke
Primary Purpose
Chronic Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Vibrotactile coordinated reset
Sham vibrotactile coordinated reset
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke
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 effect 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:
- 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. History of previous stroke 9. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle 10. Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months 11. Must be able to communicate with staff 12. Severe sensory abnormalities of the fingers such as vibratory urticaria
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Vibrotactile Coordinated Reset (vCR)
Sham Vibrotactile Coordinated Reset (vCR)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05490277
Brief Title
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
Official Title
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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 in stoke patients This study will include a dedicated sham that will aid in understanding true treatment effects from vCR
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Vibrotactile Coordinated Reset (vCR)
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham Vibrotactile Coordinated Reset (vCR)
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active Vibrotactile coordinated reset
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham vibrotactile coordinated reset
Intervention Description
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 Measure Information:
Title
Fugl Meyer Assessment of Motor Recovery after Stroke change from baseline, 3 months, 4 months, 7months and 8 months
Description
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
Title
Neuro Quality of Life Upper Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months
Description
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 Outcome Measure Information:
Title
Barthel Index for Activities of Daily Living change from baseline, 3 months, 4 months, 7months and 8 months
Description
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
Title
Action Research Arm Test change from baseline, 3 months, 4 months, 7months and 8 months
Description
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
Title
Timed Up and Go test change from baseline, 3 months, 4 months, 7months and 8 months
Description
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
Title
Neuro Quality of Life Lower Extremity Short Form test change from baseline, 3 months, 4 months, 7months and 8 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 effect 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:
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. History of previous stroke 9. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle 10. Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months 11. Must be able to communicate with staff 12. Severe sensory abnormalities of the fingers such as vibratory urticaria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Pfeifer
Phone
650-704-3568
Email
kpfeifer@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Yankulova
Phone
650-474-9547
Email
jessky@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Tass, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data is deidentified and may be shared with other researchers upon request
Learn more about this trial
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
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