SCS for Spinal Cord Injury

Overseen By Beth Perry, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nandan Lad, M.D., Ph.D.

Disqualifiers: Complete cord transection, Spinal instability, Psychosis, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation, a device using mild electrical pulses, can aid pain management and rehabilitation for individuals with spinal cord injuries. Researchers are testing two approaches: one group will have the stimulation activated, while the other will not, though both will continue with regular medical care and therapy. Individuals with a traumatic spinal cord injury and ongoing neuropathic pain (nerve pain lasting over three months) may be suitable for this study. Participants will be involved for about 24 months, with the option to switch treatments after three months if they initially received the placebo. This study helps researchers assess the effectiveness of this treatment compared to standard care. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in spinal cord injury treatment.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it mentions that all patients will continue receiving conventional medical management, which includes medications.

What prior data suggests that Spinal Cord Stimulation is safe for spinal cord injury patients?

Research shows that Epidural Electrical Stimulation (EES) has been studied for its safety and potential benefits in people with spinal cord injuries (SCI). Studies have found that EES, when combined with physical therapy, can help improve sensation, increase muscle strength, and reduce muscle stiffness. Other research has shown that patients experienced better movement, less pain, and an improved quality of life after EES treatment.

While these findings are promising, ensuring the safety of EES remains crucial. One study found EES to be safe and effective for improving hand and arm functions in people with SCI. Although these studies are encouraging, they are still part of ongoing research, and all treatments can have risks. Participants should consult their doctors to understand these risks and make informed decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation (SCS) for spinal cord injury because it offers a novel approach to restoring function. Unlike traditional treatments that focus on rehabilitation and medication to manage symptoms, SCS uses epidural electrical stimulation (EES) to directly engage the spinal circuits. This method has the potential to reawaken dormant neural pathways and enhance motor recovery, offering hope for significant improvements in mobility. Additionally, the treatment is non-invasive and can be adjusted over time, providing a personalized therapeutic experience.

What evidence suggests that Spinal Cord Stimulation could be effective for Spinal Cord Injury?

Research has shown that epidural electrical stimulation (EES) can improve movement in people with spinal cord injuries. In this trial, participants will join one of two groups: "EES on" or "EES off." Studies have found that EES not only eases pain but also enhances movement and quality of life for some patients. Specifically, one study demonstrated that a patient with a lower spinal cord injury experienced better movement and less pain after EES treatment. Animal studies also support these findings, showing similar improvements in movement. Overall, EES presents a promising option for those seeking pain relief and improved movement after a spinal cord injury. ^{1 2 4 5 6}

Who Is on the Research Team?

Shivanand Lad, MD, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with traumatic thoracic spinal cord injury and chronic pain, who can consent to the study and attend required visits. Candidates must be medically stable for SCS implant surgery and rehabilitation but cannot have complete cord transection, untreated major depression, active infection or substance abuse, or be pregnant.

Inclusion Criteria

Subjects must be willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires

I have been in pain for more than 3 months.

I am medically fit for surgery and rehabilitation.

Exclusion Criteria

Subjects must not have comorbid psychosis or psychotic disorder

Subjects must not have complete cord transection

Subjects must not have active drug or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Procedure

Participants undergo a temporary trial procedure of SCS for 5-7 days to assess effectiveness

1 week

1 visit (in-person)

Treatment

Participants receive SCS ON or OFF along with CMM for 3 months. Placebo group may crossover to SCS ON after 3 months.

3 months

Multiple visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 1, 3, 6, 12, and 15 months post-implantation

9 months

Multiple visits (in-person and remote)

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulation

Trial Overview The study compares Spinal Cord Stimulation (SCS) plus conventional medical management (CMM) against CMM alone in managing SCI pain and aiding rehabilitation. Participants will either receive SCS turned on or off randomly while continuing CMM like medications and physical therapy for a year.

How Is the Trial Designed?

Group I: EES on Experimental Treatment 1 Intervention

Patients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments.

Group II: EES off Placebo Group 1 Intervention

Patients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point.

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)
• Phantom limb/stump pain
• Ischemic pain of vascular origin
• Complex regional pain syndrome
• Pain after an amputation
• Visceral abdominal pain and perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Who Is Running the Clinical Trial?

Nandan Lad, M.D., Ph.D.

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

In a study of 25 patients with chronic motor complete spinal cord injury, spinal cord epidural stimulation (scES) was found to be safe, with only 8% experiencing infections and 12% requiring additional procedures, while all participants achieved voluntary movement after the intervention.

The majority of patients (85%) reported that scES met or exceeded their expectations, and 100% expressed willingness to undergo the procedure again, indicating significant improvements in motor function and quality of life after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. Boakye, M., Ball, T., Dietz, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8374568/

Epidural electrical stimulation for spinal cord injury - PMC In multiple animal models of spinal cord injury, epidural electrical stimulation of the spinal cord has demonstrated a recovery of motor function.

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

Epidural Electrical Stimulation for Functional Recovery in ... Epidural electrical stimulation (EES) has emerged as a promising treatment for spinal cord injury (SCI). However, the therapeutic potential ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666634025001333

Epidural electrical stimulation facilitates motor recovery in ... In their study, a patient with T11–T12 SCI showed improved motor function, reduced pain, and enhanced quality of life. Summary. Background.

5. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... ARCEX Therapy was found to be safe and effective in 72% of participants to mediate improvements of strength and function in the hands and arms ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07207798

Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3) The primary objective of this clinical trial is to investigate the efficacy of Epidural Electrical Stimulation (EES) in restoring motor and sensory function ...