Spinal Cord and Nerve Stimulation for Spinal Cord Injury

Overseen By Gail Forrest, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Tricyclics, Neuroleptics

Disqualifiers: Ventilator, Untreated disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: 25

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve arm and hand function in people with neck-level spinal cord injuries. It combines spinal cord and nerve stimulation with physical therapy. The trial includes two groups: one receives spinal cord transcutaneous stimulation (a non-invasive method using electrical currents) alone, while the other receives both paired spinal cord and peripheral nerve stimulation. The goal is to determine if these treatments can help participants perform everyday tasks more easily. Suitable candidates are individuals with a stable neck spinal cord injury who experience weak arm and hand movements. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance daily living for participants.

Will I have to stop taking my current medications?

The trial requires participants to stop taking anti-spasticity medications and tricyclic antidepressants or neuroleptics. If you are on these medications, you will need to wean off them before participating.

What prior data suggests that this spinal cord and nerve stimulation is safe for spinal cord injury patients?

Research has shown that spinal cord and peripheral nerve stimulation is generally safe and well-tolerated. Studies indicate that these methods are safe and reversible if needed, with most issues related to the equipment rather than the treatment itself. This means that while problems can occur, they usually stem from the device, not the procedure.

For spinal cord transcutaneous stimulation, a non-invasive method using electric currents, studies also confirm its safety. Participants found the treatment manageable, indicating it wasn't too hard or uncomfortable to undergo. This method showed positive results in aiding individuals with spinal cord injuries.

In summary, various studies have demonstrated the safety of both spinal cord and nerve stimulation treatments. While some issues can arise, they are typically linked to the devices, not the treatment itself. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about spinal cord and peripheral nerve stimulation for spinal cord injury because it offers a new approach compared to traditional treatments like surgery or medication. Unlike these methods, which often focus on managing symptoms, this technique directly targets the nervous system by combining spinal cord transcutaneous stimulation (scTS) with peripheral nerve stimulation (PNS). This combination may enhance neural recovery and improve motor function more effectively. Additionally, the use of non-invasive stimulation methods could mean fewer side effects and a more accessible treatment option for patients.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that using both spinal cord and peripheral nerve stimulation can greatly improve movement in people with spinal cord injuries. One study demonstrated that this treatment improved hand function by 0.74 points on a scale, highlighting its effectiveness. Participants in this trial may receive the paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS), which has been shown to enhance movement in weak or even paralyzed muscles.

For those in the trial receiving spinal cord transcutaneous stimulation (scTS) alone, research has shown it is safe and effective for improving arm function in people with long-term spinal cord injuries. Specifically, 72% of participants in one study reached or surpassed important improvement levels in function. These findings suggest that both treatments in this trial can help restore arm and hand function in those with spinal cord injuries. ^{2 6 7 8 9}

Who Is on the Research Team?

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injuries in the neck region, leading to arm and hand paralysis or weakness. Participants should be seeking to improve their ability to perform daily tasks using their arms and hands.

Inclusion Criteria

* Non-progressive cervical SCI

* Greater than or equal to 6-months post spinal cord injury

* Stable medical condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-training Assessment

Participants undergo pre-training assessments including medical evaluation, ASIA Impairment Scale, MVC grip strength, and nerve intactness study

1 week

1 visit (in-person)

Treatment

Participants receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy, or paired scTS and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy

4 weeks

20 visits (in-person)

Post-training Assessment

Participants undergo post-training assessments to evaluate the effects of the treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Paired spinal cord and peripheral nerve stimulation
• Spinal cord transcutaneous stimulation

Trial Overview The study tests a combination of spinal cord transcutaneous stimulation and peripheral nerve stimulation paired with physical therapy training, aiming to enhance arm and hand function in those affected by spinal cord injury.

How Is the Trial Designed?

Group I: scTS+PNS Experimental Treatment 1 Intervention

This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy.

Group II: scTS Active Control 1 Intervention

This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

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]

The median time to explantation of high frequency 10 kHz spinal cord stimulators was found to be 3.5 years, with significant explantation rates of 11.1% at 1 year, 22.2% at 2 years, and 32.5% at 3 years among 126 patients studied.

Despite previous studies showing high efficacy of high frequency SCS for lower and leg pain, this study revealed a higher than expected explantation rate, highlighting the need for more longitudinal data to assess the long-term effectiveness and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics. Wang, VC., Bounkousohn, V., Fields, K., et al.[2022]

Trans-spinal direct current stimulation (tsDCS) can be safely applied in patients with spinal implants, as the presence of these implants does not significantly increase the risk of hazardous current density levels during stimulation.

The study found that while spinal implants can influence peak current density, the levels remain well below those that could cause tissue damage, ensuring that tsDCS remains a viable treatment option for individuals with spinal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling Trans-Spinal Direct Current Stimulation in the Presence of Spinal Implants. Kuck, A., Stegeman, DF., van Asseldonk, EHF.[2020]

The risk of neurologic injury from the surgical implantation of paddle type spinal cord stimulation electrodes is low, estimated at below 0.6%, based on primary data analysis.

Despite the rarity of these complications, the study emphasizes the importance of implementing preoperative, intraoperative, and postoperative measures to further minimize risks and improve procedural safety, along with careful patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. Levy, R., Henderson, J., Slavin, K., et al.[2022]

The Parastep method, a functional electrical stimulation device, enabled 13 out of 15 spinal cord-injured patients to achieve independent ambulation with a walker after an average of 20 training sessions, demonstrating its potential for improving mobility.

Despite its benefits, the Parastep method has limited applications for daily mobility due to high energy costs and cardiovascular strain, although it can still provide significant psychological and physical fitness benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. Brissot, R., Gallien, P., Le Bot, MP., et al.[2019]

Cervical intraspinal microstimulation (ISMS) shows promise in improving forelimb function after incomplete spinal cord injuries, suggesting it can activate spinal circuits below the injury site.

Therapeutic ISMS may support long-term recovery by promoting neuron survival and growth, indicating its potential as a treatment for enhancing motor control in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic intraspinal stimulation to generate activity and promote long-term recovery. Mondello, SE., Kasten, MR., Horner, PJ., et al.[2021]

In a study involving humans with chronic incomplete spinal cord injury (SCI), paired corticospinal-motoneuronal stimulation (PCMS) during voluntary muscle activity (PCMSactive) significantly enhanced corticospinal transmission compared to PCMS at rest (PCMSrest).

The results indicate that engaging in voluntary muscle contractions while undergoing PCMS can improve the effectiveness of the treatment, suggesting a potential strategy to enhance spinal plasticity and recovery in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentiating paired corticospinal-motoneuronal plasticity after spinal cord injury. Bunday, KL., Urbin, MA., Perez, MA.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925002569

Paired associative stimulation improves outcomes when ... Patients with incomplete cervical SCI were randomized 1:1 within 1–4 months post-injury to receive 12 weeks of PAS or sham stimulation alongside ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5610384/

Long-Term Paired Associative Stimulation Enhances Motor ... The PAS hand improved by 0.74 ± 0.18 points (p < 0.0001, n = 100 muscles from 5 patients), whereas the PNS hand improved by 0.55 ± 0.08 points (p < 0.0001, n = ...

3. tandfonline.com tandfonline.com/doi/abs/10.1080/17434440.2024.2358048

Paired associative stimulation to enhance motor outcome ... Available evidence showed an increase in motor outcomes after PAS stimulation. Indeed, both clinical and neurophysiological outcomes suggest the effectiveness ...

4. nature.com nature.com/articles/s41598-022-16811-1

Optimal peripheral nerve stimulation intensity for paired ... High-PAS applied as a long-term treatment can enhance motor output in weak muscles and return some movement to paralyzed muscles after ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1464336/full

Paired nerve stimulation with selective compensation effect Patients have reported overall improvement and muscle-relaxing effects on affected limbs during stimulation, suggesting a need for further ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329040/

Spinal Cord Stimulators: An Analysis of the Adverse Events ... Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%).

7. academic.oup.com academic.oup.com/painmedicine/article/17/2/325/2460710

Complications of Spinal Cord Stimulation and Peripheral ... Spinal cord and peripheral neurostimulation techniques are safe and reversible therapies. Hardware-related complications are more commonly observed than ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ejn.15191

A novel paired associative stimulation protocol with a high‐ ... We observed a therapeutic effect of high-PAS in 20 patients with incomplete SCI with wide range of injury severity, age, and time since injury.

9. nature.com nature.com/articles/scsandc201616

Long-term paired associative stimulation can restore ... It is not known whether paired associative stimulation can strengthen neuronal connections persistently and have therapeutic effects that are ...