Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Control of Incomplete Spinal Cord Injury-Related Spasticity by Means of Vibrotactile Coordinated Reset Fingertip Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290609
• Other study ID #: 72799
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Jessica Yankulova
• Phone: 650-474-9547
• Email: jessky[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks.