Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injuries; Spasticity, Muscle
• Interventions: Device: Vibrotactile Coordinated Reset

• Registration Number: NCT06290609
• Lead Sponsor: Stanford University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Status Verified: 2024-08
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2026-03-15
• Primary Completion: 2028-06-15
• Study Completion: 2028-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age at the time of enrollment: Any adult ages 18 and over
2. Spinal Cord Injury: ASIA C or D injury at level C1-T1
3. Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental
4. Spasticity with a of MAS score >3 present in upper extremities.
5. Fluent in English
6. 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.
7. Appropriate social support if required during an off-medication state.
8. 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.
9. Feels comfortable going off certain spasticity related medication during in-person study visits
10. Lives in the United States

Exclusion Criteria

1. Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips.
2. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
3. Any current drug or alcohol abuse.
4. 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.
5. Pregnancy, breast-feeding or wanting to become pregnant.
6. Physical limitations unrelated to spasticity that would affect motor ratings.
7. Craniotomy
8. Brain surgery
9. Patient is unable to communicate properly with staff (i.e., severe speech problems)
10. Medications that may affect relevant synaptic plasticity
11. Concurrent Botox treatment
12. A type of hairstyle that would impede the use of an EEG cap.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States