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Not yet recruiting NCT06290609

Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

No phase Interventional Spasticity, Muscle Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibrotactile Coordinated Reset.
Who it may be relevant to
Registry conditions: Spasticity, Muscle, Spinal Cord Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change from baseline in spasticity with the Modified Ashworth Scale (MAS) at 2 hours, 1 week, 4 weeks, and 12 weeks. [Time frame: Baseline, 2 hours, 1 week, 4 weeks, and 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT06290609 · 72799

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗