Spinal Cord Stimulation for Spinal Cord Injury

Overseen by Chet Moritz, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Must not be taking: Tizanidine, Dantrolene, Diazepam

Disqualifiers: Seizures, Headaches, Neurologic diseases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a treatment that uses electrical signals sent through the skin to help people with spinal cord injuries improve arm movement and reduce muscle stiffness. The treatment involves placing electrodes on the neck and using sensors to detect movement. The goal is to see if this method can better help patients regain function and reduce stiffness.

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 data supports the effectiveness of the treatment Closed-loop Stimulation for Spinal Cord Injury?

Closed-loop spinal cord stimulation (SCS) has shown effectiveness in treating chronic pain by automatically adjusting stimulation based on real-time feedback from the spinal cord, which helps maintain consistent therapeutic effects. This approach has been successful in managing pain and could potentially be adapted to help restore function after spinal cord injury, as it allows for precise control of stimulation and compensates for changes in the body. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is considered a safe and reversible treatment for conditions like chronic pain, with studies showing it can be used effectively in real-world settings. However, the risks associated with certain procedures, like paddle electrode removal, are not well defined in the literature. ^{1 5 6 7 8}

How does the closed-loop spinal cord stimulation treatment differ from other treatments for spinal cord injury?

Closed-loop spinal cord stimulation is unique because it automatically adjusts the strength of electrical pulses in real-time based on feedback from the spinal cord, ensuring consistent stimulation despite changes in posture or activity. This approach contrasts with traditional open-loop systems that use fixed settings, which can lead to inconsistent results. ^{1 3 4 5 9}

Research Team

Chet Moritz, Ph.D.

Principal Investigator

University of Washington

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Closed-loop Stimulation (Spinal Cord 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.

Participant Groups

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+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

3. New Zealand 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. [2023]

4. England 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. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing. [2022]

6. England 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. [2023]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

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

Postural Changes in Spinal Cord Stimulation Thresholds: Current and Voltage Sources. [2023]

9. Switzerland 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. [2020]