Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06290609
Status
Not Yet Recruiting

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Conditions

  • Spasticity, Muscle
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vibrotactile Coordinated Reset — DEVICE
    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 Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Aug 2024
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vibrotactile Coordinated Reset stimulation
    Participants will receive vCR stimulation, involving vibratory stimulation of the fingertips, with the Stanford CR Glove on a daily or weekly basis.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Peter Tass, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Stanford, CA

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