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NCT Number: NCT06290609

Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location contact

Peter Tass, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Yankulova

CONTACT

[email protected]

650-474-9547

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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