Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vibrotactile Coordinated Reset
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Vibrotactile Coordinated Reset stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2 hours, 1 week, 4 weeks, and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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