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
Qualifiers
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
Treatments tested in this trial
- Vibrotactile Coordinated Reset
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov