Brain-Controlled Spinal Stimulation for Spinal Cord Injury

Overseen By Christina Thruston, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Investigational drugs

Disqualifiers: Brain injury, Stroke, Multiple sclerosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 12 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).

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

The trial protocol does not specify if you need to stop taking your current medications, but it excludes individuals on investigational drugs or any intervention that could affect neuromotor function.

What data supports the effectiveness of the treatment BCI-TSCS for spinal cord injury?

Research shows that transcutaneous spinal cord stimulation (tSCS), a component of BCI-TSCS, can help improve motor function in people with spinal cord injuries by stimulating the spinal cord non-invasively. Studies have found that tSCS can enhance sensorimotor recovery and facilitate motor responses, suggesting its potential effectiveness in rehabilitation. ^{1 2 3 4 5}

Is Brain-Controlled Spinal Stimulation generally safe for humans?

Transcutaneous spinal cord stimulation (tSCS), a component of the treatment, is non-invasive and has been studied in people with spinal cord injuries, showing it can stimulate spinal circuits without major safety concerns. However, more specific safety data for the combined use with brain-computer interfaces is limited. ^{1 6 7 8 9}

How is the treatment BCI-TSCS different from other treatments for spinal cord injury?

BCI-TSCS is unique because it combines brain-computer interface technology with transcutaneous spinal cord stimulation, allowing for non-invasive stimulation of the spinal cord to enhance motor function. This approach is novel as it potentially enables the brain to directly influence spinal cord activity, which is different from traditional methods that do not integrate brain signals. ^{1 2 3 10 11}

Research Team

Matija Milosevic, PhD

Principal Investigator

University of Miami - MSOM

Eligibility Criteria

This trial is for adults aged 21-70 with an incomplete spinal cord injury at or above T10 level, who are more than 6 months post-injury. Participants must have some detectable motor function in their legs and be able to walk at least 10 meters with assistance. They should commit to a 6-month training program and not have metal implants affected by magnetic stimulation, severe spasticity, skin breakdown where electrodes attach, recent seizures, major cognitive issues, or substance disorders.

Inclusion Criteria

I can commit to a 6-month intensive training and assessment program.

I have muscle movement in at least 2 muscles on each side of my body, confirmed by a muscle test.

I have a spinal cord injury above T10 and it's been over 6 months since the injury.

Exclusion Criteria

Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS

I don't have conditions that prevent me from having TMS or TSCS.

I have a urinary tract infection, unhealed fracture, contracture, or pressure sore.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) therapy

up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• BCI-TSCS

Trial Overview The study tests Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) therapy aimed at improving walking ability in people with incomplete SCI. It involves intensive training sessions over six months using BCI-TSCS technology to stimulate the spinal cord and potentially enhance mobility.

Participant Groups

Group I: Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) Experimental Treatment 1 Intervention

Subjects will participate in the therapy for up to 12 months

BCI-TSCS is already approved in United States, Switzerland for the following indications:

Approved in United States as BCI-TSCS for:

• Improving walking in individuals with incomplete spinal cord injury (SCI)

Approved in Switzerland as BCI-TSCS for:

• Rehabilitation of walking in individuals with incomplete spinal cord injury (SCI)

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

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]

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]

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]

Transcutaneous spinal cord stimulation (TSS) significantly affects brain activity, activating key areas related to movement control and planning, as shown by EEG analysis in five participants performing lower-limb tasks.

TSS resulted in notable changes in functional connectivity in the brain during stimulation, unlike functional electrical stimulation (FES), suggesting TSS may be more effective for enhancing cortical engagement in rehabilitation strategies for spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. Steele, AG., Manson, GA., Horner, PJ., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

Transcutaneous spinal direct current stimulation (tsDCS) can modulate corticospinal excitability in individuals with chronic incomplete spinal cord injury, showing trends of increased excitability on one side and decreased on the other, depending on the stimulation polarity.

In a study with six participants, no significant differences were found between stimulation conditions, but the results suggest that further research is needed to optimize electrode placement and explore the potential for improved movement function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. Powell, ES., Carrico, C., Salyers, E., et al.[2018]

Transcranial magnetic stimulation-based closed-loop (TBCL) therapy significantly improves activity of daily living (ADL) gains in spinal cord injury (SCI) patients compared to sole rehabilitation, with a lower cumulative inefficiency observed at 1, 90, and 180 days.

The study, which included 768 SCI patients, found that TBCL was an independent positive factor for ADL improvement across various injury types and severities, suggesting its broad applicability in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation-based closed-loop modality for activity of daily living gain in spinal cord injury: a retrospective study using propensity score matching analysis. Liu, Y., Huang, B., Huang, G., et al.[2023]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

References

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

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]

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

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. [2018]

10. Italy pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation-based closed-loop modality for activity of daily living gain in spinal cord injury: a retrospective study using propensity score matching analysis. [2023]

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

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]