Clinical trial NCT06290609: Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury
Official title: Control of Incomplete Spinal Cord Injury-Related Spasticity by Means of Vibrotactile Coordinated Reset Fingertip Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spasticity, Muscle
Spinal Cord Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group of participants who will receive active treatment with the experimental stimulation device will be studied.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks.
timeFrame: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: