Chronic StrokeNCT05490277
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
A study testing Active Vibrotactile coordinated reset in people with Chronic Stroke, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Active Vibrotactile coordinated reset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 15 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Chronic Stroke
- Being tested
- Active Vibrotactile coordinated reset, Sham vibrotactile coordinated reset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Vibrotactile coordinated resetDevice
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 resetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Vibrotactile Coordinated Reset (vCR) | Active comparator | 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. Receives: Device: Active Vibrotactile coordinated reset |
| Sham Vibrotactile Coordinated Reset (vCR) | Sham comparator | 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. Receives: Device: Sham vibrotactile coordinated reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
Secondary outcomes (6)
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
Patients receive vibratory stimuli on a finger and indicate when stimuli are felt by pressing a button.
Measured: 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
Patients receive vibratory stimuli on two fingers either simultaneously or at different times and indicate the perceived timing by pressing a button.
Measured: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start15 Jan 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Tass, MD, PhD, Stanford University
- Investigators
- Peter A Tass, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490277
- Sponsor's protocol ID
- 65197
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data is deidentified and may be shared with other researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke
- ClinicalTrials.gov ID
- NCT05490277
- Acronym / sponsor ID
- 65197
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Vibrotactile Coordinated Reset (vCR) | Active comparator | Device: Active Vibrotactile coordinated resetVibrotactile 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. |
| Sham Vibrotactile Coordinated Reset (vCR) | Sham comparator | Device: Sham vibrotactile coordinated resetVibrotactile 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Vibrotactile coordinated resetParticipants 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 | Active Vibrotactile Coordinated Reset (vCR) |
| Sham vibrotactile coordinated resetParticipants 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. | Device | Sham Vibrotactile Coordinated Reset (vCR) |
Primary outcome
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
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
Time frame: This clinical assessment will be done at baseline visit, three month visit, four month visit, seven month visit and eight month visit
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data is deidentified and may be shared with other researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter A Tass, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Vibrotactile coordinated reset in people with Chronic Stroke, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Yankulova (650-474-9547, jessky@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.