Spinal Stimulation for Traumatic Brain Injury

(DOD SS Trial)

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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation for Traumatic Brain Injury?

Research shows that transcutaneous spinal cord stimulation (tSCS) has been effective in promoting motor recovery in individuals with spinal cord injuries, suggesting it might help with similar recovery processes in traumatic brain injury. The treatment is non-invasive and has been used to stimulate spinal circuits, which can facilitate motor responses and potentially aid rehabilitation. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation has been shown to be relatively safe for treating pain, with low rates of complications such as spinal cord injury (0.5%) and other perioperative issues. No deaths were reported in a large study, suggesting it is generally safe for humans when used appropriately. ^{6 7 8 9 10}

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for traumatic brain injury?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, potentially improving motor function by modulating spinal circuitry. Unlike other treatments, tSCS can target specific spinal segments to enhance sensorimotor recovery, which is particularly novel for conditions like traumatic brain injury where standard treatments are limited. ^{2 4 11 12 13}

What is the purpose of this trial?

The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal stimulation in patients with intrathecal baclofen pump delivery system: A preliminary safety study. [2023]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

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

Review of Efficacy and Safety of Spinal Cord Stimulation in Veterans. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

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

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

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

Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER. [2018]

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

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Optimization of Transspinal Stimulation Applications for Motor Recovery after Spinal Cord Injury: Scoping Review. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Contralateral Selectivity of Upper-Limb Motor Pools via Targeted Stimulation of the Cervical Spinal Cord. [2023]