Spine and Brain Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Emelly Carrasco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jason Carmel

Must not be taking: Seizure threshold-lowering

Disqualifiers: Seizures, Bipolar, Heart disease, others

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

Compensation: Varies

Number of Visits: 29

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy to help individuals with spinal cord injuries regain movement in their arms and hands. Researchers aim to determine if combining electrical stimulation of the upper spine and brain can enhance arm and hand function. Participants will undergo a combination of epidural spinal cord stimulation and paired spine and brain stimulation over 29 days. The trial seeks individuals who have had a spinal cord injury for more than a year and retain some arm movement. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for spinal cord injuries.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that lower the seizure threshold, you may need to stop those to participate.

What prior data suggests that this method is safe for improving arm and hand function after spinal cord injury?

Research has shown that epidural spinal cord stimulation (eSCS) is generally safe, similar to its use for treating chronic pain, meaning most people tolerate it well. One study found that using eSCS for spinal cord injuries did not cause more side effects than expected, including effects on movement and other functions.

Another study examined the long-term effects and also found eSCS to be safe, identifying no major safety issues over time. While the treatment aims to improve movement in the arms and hands, current evidence suggests it is safe for people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for spinal cord injuries, which often includes physical therapy and medications to manage symptoms, epidural spinal cord stimulation offers a more direct approach by targeting the spinal cord itself. This technique involves placing electrodes on the spinal cord to stimulate nerve activity, potentially enhancing motor functions and providing more immediate improvements. Researchers are excited about this treatment because it pairs stimulation with structured rehabilitation, which may accelerate recovery and improve outcomes significantly compared to traditional methods. This innovative approach could offer new hope for those with spinal cord injuries, paving the way for faster and more effective rehabilitation.

What evidence suggests that this trial's treatments could be effective for improving arm and hand function after cervical spinal cord injury?

Research has shown that epidural spinal cord stimulation, which participants in this trial may receive, can significantly improve movement in people with spinal cord injuries. In one study, 44% of participants could take steps with assistance or independently, or stand up, and 87% demonstrated some improvement in movement. Another treatment option in this trial is paired spine and brain stimulation. Studies suggest that using spine and brain stimulation together can enhance movement by creating lasting changes in nerve pathways. This combined method has shown promise in improving movement and muscle control. Both treatments in this trial aim to help people regain use of their arms and hands after spinal cord injuries. ^{4 5 6 7 8}

Who Is on the Research Team?

Jason B. Carmel, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with incomplete traumatic spinal cord injury between C4 to T1, who have some motor power in at least one upper extremity muscle group. Participants must be able to understand and follow instructions and consent to the study. Exclusions include a history of suicide attempts, ongoing ventilator use, certain metal implants or brain stimulators, severe psychiatric disorders, substance abuse affecting seizure risk, pregnancy plans during the study period, specific medical conditions or treatments that could interfere with the trial.

Inclusion Criteria

English speaking

International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50

Ability and willingness to provide informed consent

Exclusion Criteria

Any history of suicide attempt

Any ongoing ventilator use (continuous or intermittent)

Intracranial aneurysm clips

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo temporary placement of cervical epidural spinal cord stimulation (SCS) electrodes and participate in a series of experiments over 29 days to study the effects of SCS and brain stimulation on arm and hand function.

4 weeks

Daily visits for 29 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of adverse events and tolerability.

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Spinal Cord Stimulation
• Paired Spine and Brain Stimulation

Trial Overview The trial tests whether combining cervical spinal cord stimulation (electrical wires implanted near the spine) with transcranial magnetic brain stimulation can improve arm and hand function after an upper spinal cord injury. Over 29 days, experiments will assess if this dual approach offers functional benefits.

How Is the Trial Designed?

Group I: Epidural Spinal Cord Stimulation Experimental Treatment 1 Intervention

Participants will undergo temporary placement of cervical epidural spinal cord stimulation (SCS) electrodes. They will undergo 2 visits of stimulation optimization based on mapping of motor responses to SCS and clinical assessments at a range of SCS parameters. Once a stimulation plan has been established, subjects will undergo baseline assessments with and without SCS over 2 visits. Subjects will then undergo 15 days of continuous SCS in conjunction with structured rehabilitation with occupational therapy. On each day of therapeutic stimulation, subjects will receive two sessions of SCS plus structured rehabilitation (for up to 1.5 hours per session). Subjects will undergo a clinical assessment with and without stimulation at the midpoint of the therapeutic stimulation period. After this therapeutic stimulation period, subjects will undergo 2 days of repeat assessments.

Who Is Running the Clinical Trial?

Jason Carmel

Lead Sponsor

Trials

1

Recruited

20+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Pairing motor cortex stimulation with spinal cord epidural stimulation significantly enhances motor responses, particularly when the timing of the stimuli is optimized, leading to more than double the motor evoked potentials (MEPs).

Repeated stimulation of both areas not only produced immediate effects but also resulted in lasting increases in spinal excitability and MEPs, suggesting a potential therapeutic approach for improving sensorimotor function after central nervous system injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paired motor cortex and cervical epidural electrical stimulation timed to converge in the spinal cord promotes lasting increases in motor responses. Mishra, AM., Pal, A., Gupta, D., et al.[2018]

In a study involving 122 participants with chronic low back and/or leg pain, multiphase spinal cord stimulation (SCS) significantly reduced pain levels, with mean reductions of -4.3 and -4.7 on the numerical rating scale for two different multiphase therapies.

The multiphase SCS therapies were found to be safe, with only one non-serious device-related adverse event reported and no infections, suggesting a favorable safety profile for this new stimulation paradigm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Kapural, L., Patterson, DG., Li, S., et al.[2023]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

Epidural spinal cord stimulation can effectively elicit spinal motor evoked potentials (sMEPs) in forelimb muscles of rats after spinal cord injury, with the strength of these responses varying based on electrode placement and stimulation intensity.

sMEPs can serve as reliable biomarkers to optimize stimulation parameters for improving forelimb motor function, suggesting a more efficient method for determining effective treatment configurations compared to traditional empirical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. Alam, M., Garcia-Alias, G., Shah, PK., et al.[2018]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., 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 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889415/

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... Results indicated significant improvements in motor function: 44% of patients achieved assisted or independent stepping or standing; 87% showed ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322002349

Spinal Cord Stimulation Research in the Restoration of ... Motor recovery was the most common primary outcome for epidural and transcutaneous SCS studies, whereas bowel and bladder outcomes were most common for magnetic ...

3. 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.

4. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

5. spj.science.org spj.science.org/doi/10.34133/cbsystems.0314

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35701485/

The safety of epidural spinal cord stimulation to restore ... Conclusions: eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain, despite the ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07042815

Long-term Follow-up for Epidural Stimulation in SCI The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: provide ...

8. mdpi.com mdpi.com/2077-0383/13/4/1090

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... This study reviews the evolving role of epidural spinal cord stimulation (eSCS) in treating chronic SCI, focusing on its efficacy and safety.