Vibrotactile Therapy for Spinal Cord Injury

Overseen By Jessica Yankulova

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Botox, Synaptic plasticity drugs

Disqualifiers: Neuro-psychiatric problems, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests a new treatment called vibrotactile Coordinated Reset (vCR) to help individuals with spasticity (muscle stiffness) from spinal cord injuries. This treatment uses a special device, the Stanford CR Glove, which gently vibrates the fingertips to potentially ease symptoms without drugs like baclofen. It suits those who have had an incomplete spinal cord injury for at least a year and experience upper body muscle stiffness. Participants should be comfortable with technology and able to stop certain medications during study visits. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for spasticity without medication.

Will I have to stop taking my current medications?

The trial protocol suggests that you may need to stop taking certain medications that affect brain function or spasticity during specific parts of the study, like EEG recordings or in-person visits.

What prior data suggests that the Stanford CR Glove is safe for treating spasticity in spinal cord injury patients?

Research has shown that vibrotactile Coordinated Reset (vCR) is generally safe. In studies with Parkinson's disease patients, vCR was easy to tolerate and caused no side effects, making it a safe and non-invasive option. The therapy uses gentle vibrations on the fingertips to help manage symptoms without medications or surgeries. Although data for spinal cord injury patients is limited, evidence from Parkinson's studies supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for spinal cord injury, which often involve medications and physical therapy to manage symptoms and improve mobility, Vibrotactile Coordinated Reset (vCR) offers a novel approach by using vibratory stimulation on the fingertips. This method employs the Stanford CR Glove to deliver targeted vibrations, potentially enhancing neural plasticity and promoting recovery in a new way. Researchers are excited about vCR because it could provide a non-invasive, easily administered option that directly engages the nervous system, potentially offering improvements in function and sensation for spinal cord injury patients.

What evidence suggests that vibrotactile therapy is effective for spinal cord injury?

Research shows that Vibrotactile Coordinated Reset (vCR), which participants in this trial will receive, can improve movement abilities in people with neurological conditions. Studies have found that this treatment enhances coordination and control of movements. In people with Parkinson's disease, vCR has changed brain activity patterns, potentially helping to manage symptoms. Although limited data exists on its effects on spinal cord injuries, the mechanism of vCR suggests it could reduce muscle stiffness through gentle, non-invasive stimulation. Overall, early research suggests vCR might offer a new way to manage symptoms for those with spinal cord injuries. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with incomplete spinal cord injuries experiencing muscle spasms and spasticity. Participants should be able to visit the lab four times over three months. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions or factors that qualify or disqualify someone from participating.

Inclusion Criteria

Lives in the United States

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

I am okay with stopping my spasticity medication for study visits.

Exclusion Criteria

Any current drug or alcohol abuse

I have severe difficulty speaking or communicating.

I am currently receiving Botox treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vibrotactile Coordinated Reset (vCR) stimulation using the Stanford CR Glove

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Coordinated Reset

Trial Overview The study is testing a non-invasive treatment called vibrotactile Coordinated Reset (vCR), delivered through the Stanford CR Glove. This alternative therapy aims to reduce spasticity symptoms in patients, potentially offering benefits over current treatments like oral medication or deep brain stimulation.

How Is the Trial Designed?

Group I: Vibrotactile Coordinated Reset stimulation Experimental Treatment 1 Intervention

Participants will receive vCR stimulation, involving vibratory stimulation of the fingertips, with the Stanford CR Glove on a daily or weekly basis.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Targeted transcutaneous spinal cord stimulation (tSCS) in two individuals with motor-complete spinal cord injury led to a remarkable increase in exerted force by up to 1,136% when combined with weekly activity-based training.

This study is the first to report a significant improvement in tactile sensation, with a 2-point increase in clinical assessments, and the benefits persisted for at least one month after stimulation, indicating potential for lasting recovery of motor and sensory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. Chandrasekaran, S., Bhagat, NA., Ramdeo, R., et al.[2023]

An implanted neuroprosthesis significantly improved walking distance for a female participant with C6 AIS C spinal cord injury, increasing her walking distance from 95 meters to 488 meters, while also enhancing her walking speed over longer distances.

The use of electrical stimulation not only improved joint movements (like hip and knee flexion) but also reduced oxygen consumption and upper extremity forces, indicating a more efficient walking pattern with the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an implanted neuroprosthesis on community ambulation in incomplete SCI. Lombardo, LM., Kobetic, R., Pinault, G., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-spinal-cord-injuries-2-2024-5ecd2

Vibrotactile Therapy for 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8055937/

Coordinated Reset Vibrotactile Stimulation Induces Sustained ... Results. Clinically, in both studies, we observed significantly improved motor ability. EEG recordings observed from study 1 indicated a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05881460

Vibrotactile Coordinated Reset: a Non-invasive Treatment ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor function in people with Parkinson's disease ( ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.758481/full

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... In one patient, we planned a 1-month pause in stimulation after 6 months of therapy. Results showed no considerable differences in motor ability. Additionally, ...

5. researchgate.net researchgate.net/publication/350648275_Coordinated_Reset_Vibrotactile_Stimulation_Induces_Sustained_Cumulative_Benefits_in_Parkinson's_Disease

(PDF) Coordinated Reset Vibrotactile Stimulation Induces ... Methods Study 1 examines six PD patients receiving noisy vCR stimulation and their cortical beta power changes after 3 months of daily therapy. Motor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771098/

Vibrotactile coordinated reset stimulation for the treatment ... Furthermore, these results indicate that vCR may ultimately provide a safe and tolerable non-pharmacological and non-invasive treatment option for PD patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05545826

Vibrotactile Coordinated Reset (VCR): A Treatment for ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms.