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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Vibrotactile Coordinated Reset for spinal cord injury?

Research on similar treatments, like transcutaneous spinal cord stimulation (tSCS), shows promising results in improving motor control and tactile sensation in people with spinal cord injury. In a study, targeted stimulation led to significant increases in force exertion and improvements in tactile sensation, with benefits persisting even after stopping the stimulation. ^{1 2 3 4 5}

Is Vibrotactile Therapy for Spinal Cord Injury safe for humans?

The available research on spinal cord injury trials shows that safety reporting is often not detailed enough, with only 30% of trials providing satisfactory information on adverse events. This means that while some safety data exists, it may not be comprehensive or specific to Vibrotactile Therapy. ^{1 6 7 8 9}

How is Vibrotactile Coordinated Reset treatment different from other treatments for spinal cord injury?

Vibrotactile Coordinated Reset is unique because it uses vibrations to provide sensory feedback, which can help reorganize brain activity and improve motor control in people with spinal cord injuries. This approach is different from traditional therapies as it focuses on enhancing sensory input to aid in rehabilitation. ^{2 7 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing in patients with incomplete spinal cord injury. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Characterization of neurological recovery following traumatic sensorimotor complete thoracic spinal cord injury. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of sacral sensory sparing in motor complete spinal cord injury. [2022]

4. Switzerland 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Precision neuromodulation: Promises and challenges of spinal stimulation for multi-modal rehabilitation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Natural history of neurological improvement following complete (AIS A) thoracic spinal cord injury across three registries to guide acute clinical trial design and interpretation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The validity in persons with spinal cord injury of a self-reported functional measure derived from the functional independence measure. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Impact of an implanted neuroprosthesis on community ambulation in incomplete SCI. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Functional reorganization and stability of somatosensory-motor cortical topography in a tetraplegic subject with late recovery. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Vibrotactile feedback to control the amount of weight shift during walking - A first step towards better control of an exoskeleton for spinal cord injury subjects. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Adding electrical stimulation during standard rehabilitation after stroke to improve motor function. A systematic review and meta-analysis. [2018]