Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries; Spasticity, Muscle
• Intervention / Treatment: Device: Vibrotactile Coordinated Reset

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Yankulova; Phone Number: 650-474-9547; Email: jessky@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Principal Investigator: Peter Tass, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Vibrotactile Coordinated Reset; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Muscle Spasticity; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 72799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No