Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

NCT ID: NCT06290609

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2028-06-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vibrotactile Coordinated Reset

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Peter Tass, MD, PhD

Protocol Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Jessica Yankulova

Role: CONTACT

jessky@stanford.edu

650-474-9547

Other Identifiers

72799

Identifier Type: -

Identifier Source: org_study_id