Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Fatma Inanici, MD., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Tizanidine, Dantrolene, Diazepam

Disqualifiers: Seizures, Headaches, Neurologic diseases, others

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

Compensation: Varies

Number of Visits: 9

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a type of electrical stimulation, known as Closed-loop Stimulation, might help individuals with spinal cord injuries improve arm and hand movement and reduce muscle stiffness. It compares two different stimulation methods to determine which is more effective. Individuals who have experienced a spinal cord injury affecting the neck area for over a year and have difficulty with everyday tasks like dressing or eating might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance daily life for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial requires that participants do not take certain medications, specifically tizanidine, dantrolene, or diazepam. If you are taking these, you would need to stop before participating.

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

In a previous study, most patients experienced significant pain relief with closed-loop spinal cord stimulation. Approximately 80% of participants consistently activated their spinal cord, indicating good safety. Another study found that this type of stimulation offered superior pain relief over 12 months compared to other methods.

These findings suggest that closed-loop stimulation is well-tolerated. No major safety concerns emerged in these studies, demonstrating the treatment's safety for many people over an extended period. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the closed-loop spinal cord stimulation for spinal cord injuries because it represents a significant leap forward in how we approach treatment. Unlike traditional methods, which often involve continuous, open-loop stimulation, this innovative approach tailors electrical stimulation to the patient's intended movements. This personalized feedback loop can potentially enhance motor function and recovery more effectively. By directly responding to the body’s signals, closed-loop stimulation could provide a more natural and adaptive treatment experience, offering hope for improved outcomes where conventional treatments may fall short.

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

Research has shown that closed-loop spinal cord stimulation, a treatment under study in this trial, can improve movement and reduce symptoms after a spinal cord injury. In one study, patients reported significantly less pain, with over 80% experiencing relief after 12 months. Another study found that this method provided better pain relief than open-loop stimulation, another treatment arm in this trial. Additionally, tests on animals demonstrated that using muscle signals to trigger stimulation improved movement in spinal cord injury models. These results suggest that closed-loop stimulation might aid in recovering arm movement and reducing muscle tightness after a spinal cord injury. ^{1 2 3 5 6}

Who Is on the Research Team?

Chet Moritz, Ph.D.

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults with a stable medical condition who have had a cervical spinal cord injury at least one year ago, can perform simple motor tasks, and attend sessions three times weekly. They must not be ventilator-dependent or have certain implants, drug abuse history, pregnancy, severe allergies, or other conditions that could interfere with the study.

Inclusion Criteria

I struggle with daily tasks like dressing or feeding due to hand issues.

My heart and lung health allows me to do arm exercises.

I can perform simple tasks when guided.

Exclusion Criteria

Unable to read and/or comprehend the consent form

I have nerve damage in my hands or feet.

I do not have any unhealed injuries or frequent infections that could affect my arm rehabilitation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurements

Participants undergo repeated baseline measurements

4 weeks

Multiple visits (in-person)

Intensive Exercise Therapy

Participants engage in intensive exercise therapy

6 weeks

3 sessions per week (in-person)

Closed-loop Stimulation

Participants receive closed-loop spinal stimulation

6 weeks

3 sessions per week (in-person)

Open-loop Stimulation

Participants receive open-loop spinal stimulation

6 weeks

3 sessions per week (in-person)

Waiting Period

Participants undergo a waiting period between stimulation treatments

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Repeated measurements once every eight weeks

What Are the Treatments Tested in This Trial?

Interventions

• Closed-loop Stimulation

Trial Overview The study tests non-invasive closed-loop electrical stimulation versus open-loop stimulation to improve hand function and reduce spasticity after spinal cord injuries. Participants will also engage in functional task practice as part of their therapy regimen.

How Is the Trial Designed?

Group I: Open-loop Stimulation Experimental Treatment 2 Interventions

Continuous stimulation

Group II: Close-loop Stimulation Experimental Treatment 2 Interventions

Intended movement-based stimulation.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

In a 36-month study involving participants with chronic pain, ECAP-controlled closed-loop spinal cord stimulation (CL-SCS) resulted in a significantly higher percentage of patients achieving at least a 50% reduction in pain compared to fixed-output open-loop stimulation (OL-SCS) (77.6% vs 49.3%).

CL-SCS not only provided better pain relief but also led to greater improvements in overall quality of life and neural activation without increasing adverse events, indicating its efficacy and safety as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Mekhail, NA., Levy, RM., Deer, TR., 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]

In a study of 149 patients with spinal cord stimulators, changing body positions significantly affected stimulation thresholds, with constant-current stimulators showing a greater increase in thresholds (44% to 82%) compared to constant-voltage stimulators (22% to 34%).

Postural changes from lying to sitting or standing often led to discomfort, especially with constant-current stimulators, indicating that patient positioning is crucial for optimizing spinal cord stimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources. North, RB., Sung, JH., Matthews, LA., et al.[2023]

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 involving 134 patients with chronic back and leg pain, ECAP-controlled closed-loop spinal cord stimulation provided significantly greater pain relief compared to fixed-output, open-loop stimulation, with 82.3% of patients in the closed-loop group achieving a 50% reduction in pain at 3 months.

The closed-loop system not only improved pain outcomes but also demonstrated greater spinal cord activation, suggesting a potential mechanism for its enhanced efficacy, while safety profiles were similar between both treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Mekhail, N., Levy, RM., Deer, TR., et al.[2020]

A new closed-loop epidural stimulation system was developed that uses EMG activity to trigger stimulation in the cervical spinal cord of rats, showing reliable operation over extended periods (7 hours per session, 6 days a week for 3 months).

This system represents a promising tool for long-term therapeutic applications and research into recovery from spinal cord injuries, as it allows for real-time interaction between neural activity and stimulation, potentially enhancing motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Activity-Dependent Epidural Stimulation System in Freely Moving Spinal Cord Injured Rats: A Proof of Concept Study. Rascoe, A., Sharma, P., Shah, PK.[2020]

Closed-loop spinal cord stimulation (CL SCS) systems can automatically adjust stimulation parameters based on real-time feedback from the evoked compound action potential (ECAP), potentially improving the consistency and effectiveness of pain management compared to traditional open-loop systems.

This innovative approach aims to enhance therapeutic outcomes by reducing variability in tissue activation, which can lead to more reliable pain relief for patients with chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing. Vallejo, R., Chakravarthy, K., Will, A., et al.[2022]

A multicenter feasibility study is underway to evaluate the effectiveness of evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (CL-SCS) in up to 300 patients with chronic pain, focusing on real-world outcomes over a 24-month period.

This innovative approach continuously adjusts stimulation based on neurophysiological feedback, which may enhance treatment personalization and improve understanding of chronic pain mechanisms, potentially leading to better patient management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. Leitner, A., Hanson, E., Soliday, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8184296/

Sustained Long-Term Outcomes With Closed-Loop Spinal ... The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000962

A systematic review of evidence comparing spinal cord ... Significant improvements in function and quality of life were observed at study endpoints ranging from 3 to 24 months following tonic SCS. No studies included ...

3. nature.com nature.com/articles/s41586-025-09028-5

Closed-loop vagus nerve stimulation aids recovery from ... CLV represents a promising therapeutic avenue for people with chronic, incomplete cervical spinal cord injury.

4. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(19)30414-4/abstract

Long-term safety and efficacy of closed-loop spinal cord ... ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03806023

EMG Triggered Closed-Loop Stimulation for Spinal Cord ... In a demonstration of closed-loop stimulation in SCI rats, target muscle electromyography (EMG) signals were used to trigger spinal cord electrical stimulation ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02924129

Safety and Efficacy Study of the Evoke™ SCS System With ... The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk ...