36 Participants Needed

Epidural Stimulation for Spinal Cord Injury

(TSEPI Trial)

TA
SJ
MA
Overseen ByManpreet A Chopra, BAMS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses electrical stimulation of the lower spinal cord to help people with severe spinal cord injuries who can't move their legs or stand. The electrical signals aim to reactivate nerves, improving movement and other bodily functions. Electrical stimulation of the spinal cord has been used for pain relief, spasticity control, and movement restoration in spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an implanted pump or use nicotine, you may not be eligible to participate.

Is epidural stimulation safe for humans?

Epidural stimulation has been reported as safe and well-tolerated in patients, with studies showing it can reduce pain and improve function in various conditions. However, there can be specific cases like muscle hypertrophy (enlargement) due to electrode shifts, so monitoring and proper placement are important.12345

How is the treatment Epidural Stimulation for Spinal Cord Injury different from other treatments?

Epidural Stimulation is unique because it involves applying electrical stimulation directly to the spinal cord, which can help restore voluntary muscle control and improve standing and walking abilities in people with spinal cord injuries. Unlike other treatments, it directly interacts with the spinal circuits to enhance motor functions, offering a novel approach to rehabilitation.56789

What data supports the effectiveness of the treatment Epidural Stimulation for Spinal Cord Injury?

Research shows that epidural stimulation can help people with spinal cord injuries regain some control over their muscles, allowing them to stand and make step-like movements. In one study, a person with paraplegia was able to stand and control muscle movements after just eight sessions of this treatment.2791011

Who Is on the Research Team?

SJ

Susan J Harkema, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe spinal cord injury, unable to stand or move legs voluntarily, and experiencing issues like low blood pressure and respiratory dysfunction. They should be at least two years post-injury with stable health but can't join if they use nicotine, have certain implants, untreated conditions, or are pregnant.

Inclusion Criteria

My spinal cord injury is not getting worse.
It has been over 2 years since my injury.
My health condition is stable.
See 5 more

Exclusion Criteria

I have not had bladder botox injections in the last year.
You require a machine to help you breathe.
You currently have an untreated mental health disorder or are actively using drugs.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks

Treatment

Participants receive lumbosacral spinal cord epidural stimulation (scES) for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing.

12 weeks
Weekly visits for stimulation and training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiovascular, respiratory, bladder, bowel, and sexual function.

8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to further assess quality of life and healthcare costs.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Epidural Stimulation
  • Stand Training
Trial Overview The study tests how epidural stimulation (scES) helps recover functions affected by spinal cord injuries. Participants will receive scES aimed at improving cardiovascular function, voluntary movement of legs/trunk, or standing ability. The impact on quality of life and healthcare costs will also be evaluated.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Voluntary Movement ES + Stand TrainingExperimental Treatment1 Intervention
Group II: Epidural Stimulation for Voluntary MovementExperimental Treatment1 Intervention
Group III: Epidural Stimulation for Cardiovascular stability during daily activitiesExperimental Treatment1 Intervention
Group IV: Cardiovascular ES + Stand TrainingExperimental Treatment1 Intervention
Group V: Acute Epidural Stimulation for Cardiovascular Stability.Experimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Epidural Stimulation for:
🇨🇦
Approved in Canada as Epidural Stimulation for:
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Approved in European Union as Epidural Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

Christopher Reeve Paralysis Foundation

Collaborator

Trials
6
Recruited
1,800+

Published Research Related to This Trial

Spinal cord epidural stimulation (SCES) not only aids in facilitating walking but also improves cardiovascular autonomic regulation and reduces spasticity in a 27-year-old male with a complete spinal cord injury, as shown in assessments conducted 15 weeks apart.
The study demonstrated that SCES can stabilize blood pressure during postural changes and significantly reduce muscle spasticity, suggesting that a single SCES configuration can provide multiple functional benefits, which may enhance its clinical application.
Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report.Gorgey, AS., Goldsmith, J., Alazzam, A., et al.[2023]
Epidural electrical stimulation (EES) has shown promise in restoring motor functions in two human subjects with complete paralysis due to spinal cord injury, enabling intentional control of step-like activity within just five days after implantation.
The study highlights the effectiveness of using EES-evoked motor responses to guide the precise positioning of electrode arrays during surgery, ensuring stable and targeted stimulation of spinal cord regions associated with lower limb movement.
Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis.Calvert, JS., Grahn, PJ., Strommen, JA., et al.[2020]
Epidural electrical stimulation (EES) of the lumbosacral spinal cord allowed a patient with chronic traumatic paraplegia to achieve significant motor control, including voluntary movement of muscles for specific tasks and rhythmic movements within just 2 weeks of therapy.
This case demonstrates the potential of EES to enable independent standing and controlled movements in patients with severe spinal cord injuries, highlighting its efficacy as a promising intervention for restoring motor function.
Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia.Grahn, PJ., Lavrov, IA., Sayenko, DG., et al.[2017]

Citations

Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]
Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. [2020]
Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. [2017]
Neuromodulation of evoked muscle potentials induced by epidural spinal-cord stimulation in paralyzed individuals. [2021]
The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. [2021]
Hypertrophy of paravertebral muscles after epidural electrical stimulation shifted: A case report. [2022]
Epidural spinal electrostimulatory system (ESES) in the management of diabetic foot and peripheral arteriopathies. [2019]
Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial. [2022]
Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. [2022]
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]
[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. [2006]
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