Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Tyson L. Scrabeck

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Peter J. Grahn, Ph.D.

Disqualifiers: Pregnancy, Untreated UTI, Psychiatric disorder, others

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

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

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of spinal cord stimulation affect nerve activity and movement in individuals with spinal cord injuries. Participants will receive either epidural stimulation, applied to the outer layer of the spinal cord, or dorsal root stimulation, targeting specific nerve roots, during rehabilitation sessions. It suits those who have experienced a traumatic spinal cord injury at or above the lower back (10th thoracic vertebra) for over a year and continue to experience effects but still have reflexes below the injury. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance rehabilitation techniques for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team to understand any specific requirements.

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

Research has shown that stimulating the dorsal root ganglion can effectively treat long-term pain. Several studies indicate that patients generally tolerate this method well, handling it without major issues. Meanwhile, researchers are investigating the safety and effectiveness of epidural spinal cord stimulation for spinal cord injuries. Although detailed safety information is not provided, these treatments have been used in other situations, suggesting they are reasonably safe.

Both treatments involve placing small devices called electrodes to stimulate nerves, which are removed after the trial. While not all possible side effects are listed, current evidence suggests they are generally manageable. Participation in this trial can contribute to further improving these therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about percutaneous epidural and dorsal root stimulation (ES and DRS) for spinal cord injury because it offers a novel approach to recovery. Unlike standard treatments that mainly focus on managing symptoms or promoting physical rehabilitation, this technique directly stimulates the spinal cord and its associated nerves through implanted electrodes. This method aims to enhance the body's natural recovery processes by improving neural connectivity and function. The use of percutaneously implanted electrodes allows for targeted stimulation, potentially leading to better outcomes in motor and sensory improvements than traditional therapies.

What evidence suggests that percutaneous epidural and dorsal root stimulation is effective for spinal cord injury?

Studies have shown that stimulating the dorsal root ganglion can lead to better treatment success with fewer side effects compared to other methods. Research indicates that stimulating the spinal cord through the epidural space can improve movement in people with long-term spinal cord injuries. In this trial, participants will receive both epidural stimulation (ES) and dorsal root stimulation (DRS) together. Early findings suggest this combination might enhance results, offering better movement and pain relief. Each method targets different nerve areas to help restore function and reduce pain. While more research is needed, these techniques show promising results for improving life after a spinal cord injury. ^{2 3 4 6 7}

Who Is on the Research Team?

Peter J. Grahn, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 22 with spinal cord injuries from trauma above the tenth thoracic vertebrae, at least one year post-injury. They must have certain levels of injury severity (ASIA A-D) and intact reflexes below the injury. Women should agree to use contraception. Exclusions include pregnancy, unhealed wounds, non-MRI-compatible devices, active trials participation, seizures, severe health conditions affecting protocol adherence or safety.

Inclusion Criteria

My spinal cord injury happened over a year ago.

I am 22 years old or older.

I am willing to use birth control during the study.

Exclusion Criteria

Pregnancy at the time of screening for trial enrollment

I have a spine condition that could interfere with spinal electrode implantation.

I currently have a urinary tract infection that hasn't been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) delivered via percutaneously implanted electrodes during rehabilitation sessions

4 weeks

10 rehabilitation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Percutaneous epidural and dorsal root stimulation

Trial Overview

The study tests two types of stimulation: epidural and dorsal root ganglion stimulation in individuals with spinal cord injuries. Over ten rehab sessions, it measures changes in motor performance and electrical activity within the spine to see which method might be more effective.

How Is the Trial Designed?

Group I: Percutaneous ES and DRS Experimental Treatment 1 Intervention

Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

Percutaneous epidural and dorsal root stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Spinal cord stimulation for:

• Severe and chronic pain of the trunk or limbs refractory to all other pain therapies

Approved in United States as Dorsal root ganglion stimulation for:

• Severe and chronic pain of the trunk or limbs refractory to all other pain therapies

Approved in Canada as Spinal cord stimulation for:

• Chronic neuropathic pain syndromes

Approved in European Union as Dorsal root ganglion stimulation for:

• Chronic neuropathic pain syndromes

Who Is Running the Clinical Trial?

Peter J. Grahn, Ph.D.

Lead Sponsor

Trials

1

Recruited

30+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Dorsal root ganglion (DRG) stimulation is an effective neuromodulation technique for relieving various neuropathic pain syndromes, showing similar efficacy to spinal cord stimulation (SCS) in conditions like failed back surgery syndrome and complex regional pain syndromes.

DRG stimulation has advantages over SCS and peripheral nerve stimulation (PNS), including a lower rate of electrode migration and fewer positional side effects, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the Dorsal Root Ganglion. Liem, L.[2022]

A study involving 106 patients with chronic pain showed that electrical stimulation of the dorsal neural structures in the spine can effectively generate sensory responses in areas of pain, indicating its potential for pain management.

The research identified specific body areas where stimulation is more effective, such as the hand and thigh, while noting challenges in stimulating areas like the neck and low back, highlighting the variability in response based on spinal levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping of sensory responses to epidural stimulation of the intraspinal neural structures in man. Barolat, G., Massaro, F., He, J., et al.[2011]

In a study of 50 patients with lower back and/or leg pain, the novel closed-loop spinal cord stimulation (SCS) system demonstrated long-term effectiveness, with 76.9% of patients achieving at least 50% pain relief after 12 months.

The system maintained spinal cord activation within a therapeutic window for 84.9% of the time, and 68.8% of patients were able to reduce or eliminate their opioid use, highlighting both safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. Russo, M., Brooker, C., Cousins, MJ., et al.[2021]

A new percutaneous technique for implanting spinal stimulators allows for effective pain control with minimal surgical trauma, making it a less invasive option for patients.

If initial spinal stimulation is ineffective, the same technique can be used to perform a percutaneous cordotomy, providing a quick alternative treatment for conditions like trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of chronic spinal cord electrodes for control of intractable pain: preliminary report. Hoppenstein, R.[2004]

Percutaneously inserted spinal epidural neurostimulation is a safe and simplified alternative to traditional surgical dorsal column stimulation for managing spasticity and intractable pain, as evidenced by a study of 27 tissue specimens from 15 patients.

Long-term histological analysis revealed only dense fibrous encapsulation around the implanted devices, supporting the clinical belief in the safety of this neurostimulation method over a period of up to two years post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological reaction to percutaneous epidural neurostimulation: initial and long-term results. Richardson, RR., Nunez, C., Siqueira, EB.[2004]

Dorsal root ganglion (DRG) stimulation is an emerging treatment for neuropathic pain, but complications during the placement of the device can occur, as illustrated by a case where a catheter fragment was retained in the spinal canal.

The patient required a laminectomy to remove the retained catheter, highlighting the need for further investigation into the safety and long-term complications associated with DRG stimulation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retained catheter during placement of dorsal root ganglion stimulator: a case report. Kohli, G., Amin, S., Herschman, Y., et al.[2020]

Dorsal root ganglion (DRG) stimulation can be successfully performed through open surgery in patients with previous surgeries that complicate percutaneous techniques, as demonstrated in two cases of severe radiculopathy due to foraminal stenosis.

The open placement method resulted in stable lead positioning and effective pain relief over 18 and 12 months, with lower stimulation amplitudes needed compared to traditional percutaneous methods, suggesting it is a viable alternative when percutaneous attempts fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Microsurgical Dorsal Root Ganglion Lead Placement. Piedade, GS., Cornelius, JF., Chatzikalfas, A., et al.[2022]

Dorsal root ganglion stimulation (DRGS) shows a low infection risk during the trial stage (1.03%), but the risk significantly increases during the implant stage (4.80%), indicating a need for careful monitoring and prophylaxis during this procedure.

This systematic review analyzed data from 10 studies involving 567 patients, providing the first comprehensive look at infection rates associated with DRGS at different stages, highlighting the importance of further research into infection management in this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious Complications of Dorsal Root Ganglion Stimulation: A Systematic Review and Pooled Analysis of Incidence. Moman, RN., Peterson, AA., Maher, DP., et al.[2022]

Dorsal root ganglion stimulators (DRGS) are effective in treating neuropathic pain from various causes, and they are typically placed using a minimally invasive technique under fluoroscopic guidance.

In cases where patients have challenging anatomy due to surgical scarring, an alternative open surgical approach for DRGS placement can be utilized, as demonstrated in a patient with persistent post-herpetic neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Surgical Placement of T9-T12 Dorsal Root Ganglion Stimulators With Titanium Plate Anchor Fixation in a Patient With Recalcitrant Post-herpetic Neuralgia. Johnson, R., Seibly, JM.[2021]

Percutaneous epidural stimulation for intractable pain was performed on 20 patients with no major complications, demonstrating its safety and simplicity compared to traditional methods.

The technique allowed for a trial period to assess pain relief, with 7 out of 8 patients experiencing long-term pain relief for up to 2 years, suggesting its efficacy as an alternative to dorsal column stimulator implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous epidural stimulation of the spinal cord for relief of pain. Long-term results. Urban, BJ., Nashold, BS.[2004]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8780129/

Comparison of Spinal Cord Stimulation vs. Dorsal Root ...

Comparison of spinal cord stimulation vs. dorsal root ganglion stimulation vs. association of both in patients with refractory chronic back and/or lower limb ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5359787/

Dorsal root ganglion stimulation yielded higher treatment ...

A comparative effectiveness trial indicates that dorsal root ganglion stimulation provided a higher rate of treatment success with less postural variation ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1094715922006869

Dorsal Root Ganglion Stimulation as a Salvage Therapy ...

We retrospectively included consecutive patients from 2016 to 2020 who were salvaged with DRG-S after failed SCS trials (<50% pain reduction) or who had ...

4.

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.

5.

aetna.com

aetna.com/cpb/medical/data/100_199/0194.html

Spinal Cord Stimulation - Medical Clinical Policy Bulletins

Spinal cord stimulation using more than 16 electrodes/contacts or more than 2 percutaneous leads has not been proven more effective than standard spinal cord ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7065079/

Safety Analysis of Dorsal Root Ganglion Stimulation in the ...

Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1094715923007146

Cardiovascular Effects of Spinal Cord Stimulation

Spinal cord stimulation (SCS) has been reported to modulate blood pressure (BP), heart rate (HR), and HR variability (HRV).