Spasticity, MuscleNCT06290609
Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury
A study testing Vibrotactile Coordinated Reset in people with Spasticity, Muscle and Spinal Cord Injuries, run by Stanford University at 1 site in United States.
Trial summary
The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Muscle, Spinal Cord Injuries
- What is being tested?
- Vibrotactile Coordinated Reset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at the time of enrollment: Any adult ages 18 and over
- Spinal Cord Injury: ASIA C or D injury at level C1-T1
- Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental
- Spasticity with a of MAS score >3 present in upper extremities.
- Fluent in English
- If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording.
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- Appropriate social support if required during an off-medication state.
- Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
- Feels comfortable going off certain spasticity related medication during in-person study visits
- Lives in the United States
Who cannot join
- Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips.
- Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
- Any current drug or alcohol abuse.
- Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- Pregnancy, breast-feeding or wanting to become pregnant.
- Physical limitations unrelated to spasticity that would affect motor ratings.
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- Craniotomy
- Brain surgery
- Patient is unable to communicate properly with staff (i.e., severe speech problems)
- Medications that may affect relevant synaptic plasticity
- Concurrent Botox treatment
- A type of hairstyle that would impede the use of an EEG cap.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94305
Peter Tass, MD, PhD
About this study
Official title: Control of Incomplete Spinal Cord Injury-Related Spasticity by Means of Vibrotactile Coordinated Reset Fingertip Stimulation
The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries
- Being tested
- Vibrotactile Coordinated Reset
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile Coordinated ResetDevice
The experimental device, the Stanford CR Glove, is designed to deliver vibratory stimulation to the fingertips of each hand according to a specific pattern, known as vibrotactile Coordinated Reset, which theoretically disrupts abnormal neuronal synchrony and is expected to restore function.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Coordinated Reset stimulation | Experimental | Participants will receive vCR stimulation, involving vibratory stimulation of the fingertips, with the Stanford CR Glove on a daily or weekly basis. Receives: Device: Vibrotactile Coordinated Reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.
The MAS is a method of grading muscle spasticity according to a 6-point ordinal scale. In this assessment, spasticity is judged to be present when resistance is encountered during passive muscle stretching. With a score of 0 indicating no increase in muscle flexion and a score on 4 indicating and increase in muscle flexion. Low numeric ratings indicate better outcomes and high numbers indicate worse outcome.
Measured: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of participants who will receive active treatment with the experimental stimulation device will be studied.
- Masking
- None (open label)
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290609
- Sponsor's protocol ID
- 72799
- Status last verified
- Aug 2024
- First submitted
- 26 Feb 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
- Control of Incomplete Spinal Cord Injury-Related Spasticity by Means of Vibrotactile Coordinated Reset Fingertip Stimulation
- ClinicalTrials.gov ID
- NCT06290609
- Acronym / sponsor ID
- 72799
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 4 Mar 2024 (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 (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of participants who will receive active treatment with the experimental stimulation device will be studied.
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Coordinated Reset stimulation | Experimental | Device: Vibrotactile Coordinated ResetParticipants will receive vCR stimulation, involving vibratory stimulation of the fingertips, with the Stanford CR Glove on a daily or weekly basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age at the time of enrollment: Any adult ages 18 and over
- Spinal Cord Injury: ASIA C or D injury at level C1-T1
- Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental
- Spasticity with a of MAS score >3 present in upper extremities.
- Fluent in English
Key exclusion criteria (12 listed)
- Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips.
- Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
- Any current drug or alcohol abuse.
- Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- Pregnancy, breast-feeding or wanting to become pregnant.
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 |
|---|---|---|
| Vibrotactile Coordinated ResetThe experimental device, the Stanford CR Glove, is designed to deliver vibratory stimulation to the fingertips of each hand according to a specific pattern, known as vibrotactile Coordinated Reset, which theoretically disrupts abnormal neuronal synchrony and is expected to restore function. | Device | Vibrotactile Coordinated Reset stimulation |
Primary outcome
Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.
Time frame: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks
The MAS is a method of grading muscle spasticity according to a 6-point ordinal scale. In this assessment, spasticity is judged to be present when resistance is encountered during passive muscle stretching. With a score of 0 indicating no increase in muscle flexion and a score on 4 indicating and increase in muscle flexion. Low numeric ratings indicate better outcomes and high numbers indicate worse outcome.
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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Coordinated Reset in people with Spasticity, Muscle and Spinal Cord Injuries, 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 10 inclusion and 12 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. 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?
Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks. (time frame: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks). 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.