Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

NCT06290609 | Not Yet Recruiting FDA Device

• 1 other identifier: 72799
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity, Muscle; Spinal Cord Injuries

Outcome Measures

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.

  Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks

Study Arms (1)

Vibrotactile Coordinated Reset stimulation

EXPERIMENTAL

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

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.

Vibrotactile Coordinated Reset stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fluent in English
• 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.
• Appropriate social support if required during an off-medication state.
• 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.
• Feels comfortable going off certain spasticity related medication during in-person study visits
• Lives in the United States

You may not qualify if:

• 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.
• Pregnancy, breast-feeding or wanting to become pregnant.
• Physical limitations unrelated to spasticity that would affect motor ratings.
• Craniotomy
• Brain surgery
• Patient is unable to communicate properly with staff (i.e., severe speech problems)
• Medications that may affect relevant synaptic plasticity
• Concurrent Botox treatment
• A type of hairstyle that would impede the use of an EEG cap.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jessica Yankulova

CONTACT

650-474-9547; jessky@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Director

Model Details: A single group of participants who will receive active treatment with the experimental stimulation device will be studied.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: May 15, 2025

Record last verified: 2024-08

Locations

US (1)