Spinal Stimulation for Traumatic Brain Injury

(DOD SS Trial)

Not yet recruiting at 1 trial location

Overseen By Sharon Franco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Seizure medications

Disqualifiers: Heart disease, Seizure disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether spinal stimulation can help individuals with traumatic brain injury (TBI) improve their walking. Researchers aim to determine if adding spinal cord stimulation during walking is more effective than walking without it. Participants will either receive stimulation through electrodes placed on their skin (transcutaneous spinal cord stimulation) during walking exercises or perform the same exercises with inactive electrodes. This study suits individuals who have had a non-penetrating TBI for at least two years, experience weakness on one side of the body, and can walk short distances with a walker. As an unphased trial, it offers a unique opportunity for participants to contribute to groundbreaking research that could enhance rehabilitation methods for TBI.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that major changes to medications throughout the study are not allowed. It's best to discuss your specific medications with the study physician.

What prior data suggests that transcutaneous spinal cord stimulation is safe for individuals with hemiplegic TBI?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for people. Studies have found that tSCS, when combined with activity-based therapy, is safe and effective for individuals with long-term spinal cord injuries (SCI). These studies did not identify any major safety issues or side effects, suggesting it as a promising option for other conditions like traumatic brain injury (TBI).

Another study examined how tSCS can improve arm and hand functions in individuals with neck-level spinal cord injuries. It confirmed the treatment's safety and effectiveness, with no serious side effects reported by participants.

Overall, current evidence supports the safety of tSCS. However, as with any treatment, consulting medical professionals is important to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous spinal cord stimulation for traumatic brain injury (TBI) because it offers a non-invasive approach to enhance recovery. Unlike traditional therapies that rely heavily on medication and physical therapy alone, this treatment uses electrodes placed on the skin to deliver electrical stimulation directly to the spinal cord. This unique method aims to improve walking ability by actively engaging and retraining the nervous system, potentially offering faster and more effective rehabilitation for TBI patients.

What evidence suggests that transcutaneous spinal cord stimulation is effective for hemiplegic TBI?

Research has shown that transcutaneous spinal cord stimulation (tSCS) may enhance movement in individuals with spinal cord injuries. Studies have found that tSCS, combined with activity-based training, is safe and can improve mobility. For instance, individuals with partial spinal injuries have demonstrated some improvement in their abilities. Additionally, tSCS has been associated with better hand and arm movements in other conditions. In this trial, participants with traumatic brain injuries (TBI) will be divided into two groups: one receiving active tSCS during walking training and another receiving sham stimulation. These findings suggest that tSCS might help individuals with TBI improve their walking ability. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with hemiplegic traumatic brain injury (TBI) who have difficulty moving one side of their body. Participants should be able to perform walking exercises with or without assistance.

Inclusion Criteria

Have weakness on at least one side of the body

I had a non-penetrating brain injury over 2 years ago.

I can handle and respond well to surface stimulation.

Exclusion Criteria

I have had ringing in my ears or severe hearing issues.

Hospitalization for heart-related issues within 3 months of study enrollment

Physical therapy for walking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal stimulation combined with gait training or sham stimulation for 6 weeks

6 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview

The study is testing the effectiveness of transcutaneous spinal cord stimulation during walking exercises versus doing the same exercises without such stimulation in improving mobility for TBI patients.

How Is the Trial Designed?

Group I: TBI with Stim Experimental Treatment 1 Intervention

Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord to provide stimulation during walking.

Group II: TBI with Sham Placebo Group 1 Intervention

Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord but will not provide stimulation during walking.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Published Research Related to This Trial

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

Transcutaneous spinal cord stimulation (tSCS) can non-invasively enhance sensorimotor rehabilitation by modulating spinal cord circuitry, showing promise for improving recovery after spinal cord injuries.

Single-site tSCS can influence excitability across multiple spinal cord segments, while multi-site tSCS can enhance spinal reflexes and corticospinal networks, indicating its potential for more effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. Barss, TS., Parhizi, B., Porter, J., et al.[2022]

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]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

Transspinal stimulation (TSS) is a promising non-invasive neuromodulation technique that can activate spinal cord circuits to improve motor function in individuals with spinal cord injury, as evidenced by a review of 34 studies.

The review highlighted that multisite electrode placements generally resulted in better motor responses compared to single-site placements, suggesting that optimizing stimulation parameters is crucial for enhancing treatment outcomes, although further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Transspinal Stimulation Applications for Motor Recovery after Spinal Cord Injury: Scoping Review. Rehman, MU., Sneed, D., Sutor, TW., et al.[2023]

Transcutaneous spinal cord stimulation (tSCS) at the cervical level can enhance upper-limb function in individuals with incomplete tetraplegia, as shown by significant reflex responses in upper-limb muscles during stimulation.

The study found that adjusting the intensity and location of stimulation can selectively target different motor pools, suggesting that optimizing these parameters could improve the effectiveness of tSCS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contralateral Selectivity of Upper-Limb Motor Pools via Targeted Stimulation of the Cervical Spinal Cord. Fleming, N., Taylor, C., Etzelmueller, M., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ...

We expect effect sizes to be moderate for incomplete injuries (standardized mean difference 0.5‐0.8) and minimal for complete injuries. In ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07147816

NCT07147816 | Cervical Transcutaneous SCS for TBI

The main goal of this study is to assess the immediate effects of cervical transcutaneous spinal cord stimulation (tSCS) on arm and hand motor functions after ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ...

This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

4.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ...

Transcutaneous spinal cord stimulation has shown great promise in chronic spinal cord injury rehabilitation medicine through maximizing residual ...

5.

neurology.org

neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ...

All 7 individuals experienced improved upper extremity function, with 2 improving their American Spinal Injury Association Impairment Scale (AIS) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9396932/

Transcutaneous Electrical Spinal Cord Stimulation to ...

Objective: To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity ...

7.

researchprotocols.org

researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ...

Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

8.

nature.com

nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ...

These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.