Spinal Cord and Nerve Stimulation for Spinal Cord Injury

Overseen By Pawan Sharma, 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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.

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 data supports the effectiveness of the treatment Paired spinal cord and peripheral nerve stimulation, Spinal cord transcutaneous stimulation for spinal cord injury?

Research shows that spinal cord stimulation can help people with spinal cord injuries regain some movement and control by activating nerve circuits below the injury. Additionally, peripheral nerve stimulation has been shown to restore functions like standing and stepping in individuals with spinal cord injuries. ^{1 2 3 4 5}

Is spinal cord and nerve stimulation generally safe for humans?

Research indicates that trans-spinal direct current stimulation (tsDCS) is generally safe, even in the presence of spinal implants, as the levels of current used are much lower than those that could cause tissue damage. ^{5 6 7 8 9}

How does paired spinal cord and peripheral nerve stimulation treatment differ from other treatments for spinal cord injury?

This treatment is unique because it combines stimulation of both the spinal cord and peripheral nerves, which may provide more flexible control and potentially better outcomes than using either approach alone. It aims to improve movement and control by activating neural circuits that are still functional despite the injury, offering a novel approach compared to traditional methods that often focus on a single type of stimulation. ^{1 5 9 10 11}

Research Team

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Chronic nerve health following implantation of femoral nerve cuff electrodes. [2020]

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

Potentiating paired corticospinal-motoneuronal plasticity after spinal cord injury. [2019]

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

Therapeutic intraspinal stimulation to generate activity and promote long-term recovery. [2021]

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

Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. [2022]

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

Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics. [2022]

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

Modeling Trans-Spinal Direct Current Stimulation in the Presence of Spinal Implants. [2020]

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

Large animal model for development of functional restoration paradigms using epidural and intraspinal stimulation. [2021]

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

Prediction of isometric forces from combined epidural spinal cord and neuromuscular electrical stimulation in the rat lower limb. [2023]

11. Poland pubmed.ncbi.nlm.nih.gov

[Effect of stimulation of the spinal cord on phasic and tonic reflexes in patients with central motor neuron damage]. [2015]