60 Participants Needed

Spinal Cord Stimulation for Spinal Cord Injury

JD
RM
DS
Overseen ByDimitry Sayenko, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The Methodist Hospital Research Institute
Must be taking: Anti-spasticity drugs
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 explores two methods to help people with spinal cord injuries regain the ability to stand independently. Researchers are examining epidural spinal stimulation (ESS), which uses an implanted device, and transcutaneous spinal stimulation (TSS), which works through the skin. They aim to understand how these methods can improve standing and movement for individuals with complete motor paralysis. People who have had a stable spinal cord injury for 1 to 6 years and can transfer from a wheelchair independently might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mobility options for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial requires that you maintain your current oral anti-spasticity medication regimen without changes, as approved by the study physician.

What prior data suggests that these spinal stimulation techniques are safe for spinal cord injury patients?

Research has shown that both Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal Stimulation (TSS) are promising and safe for people with spinal cord injuries.

For ESS, studies have found that it can help restore movement in animals. Although research in humans is ongoing, early results suggest safety when combined with rehabilitation. Participants using ESS have shown improvements in moving their lower limbs without major safety concerns.

TSS, which stimulates the spinal cord through the skin, has also proven safe. In trials, participants experienced functional recovery without significant side effects. Safety checks included monitoring blood pressure and skin health, with no major issues reported.

Both treatments remain under study, but current findings suggest they are well-tolerated, with no serious safety issues observed so far.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injury because they explore innovative ways to stimulate the spinal cord and potentially restore function. Unlike traditional therapies that might focus on rehabilitation and managing symptoms, Epidural Spinal Stimulation (ESS) uses an implanted device to deliver precise electrical stimulation internally, aiming to activate nerve circuits directly. On the other hand, Transcutaneous Spinal Stimulation (TSS) offers a non-invasive alternative by applying stimulation over the skin with surface electrodes, which could be more accessible and easier to administer. These methods could offer new hope for spinal cord injury patients by potentially improving movement and sensation in ways that current treatments do not.

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

This trial will compare Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal Stimulation (TSS) for people with spinal cord injuries. Research has shown that ESS, which participants in this trial may receive, can help people regain leg movement, enabling them to stand and move independently after an injury. This method uses a device placed inside the body to send electrical signals to the spine, aiding the body in relearning movement. Meanwhile, TSS, another treatment option in this trial, applies electrical signals to the skin and has improved balance, stability, and the ability to stand. Both methods have shown potential in helping patients regain some movement and independence.12467

Who Is on the Research Team?

DS

Dimitry Sayenko, MD, PhD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 22-60 with stable spinal cord injuries (1-6 years post-injury) below the neck and above the waist. They must be able to move their arms, sit upright for at least 15 minutes, and commit to the full study duration. Excluded are those with other ongoing conditions that limit physical activity, recent Botox injections in lower body muscles, or a BMI over 30.

Inclusion Criteria

Able to provide paperwork from personal primary treating physician that proves stable medical condition with ability to tolerate at least 15 minutes upright
Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study
Able to commit to the full study
See 11 more

Exclusion Criteria

I have active pressure sores, unhealed fractures, nerve pain, or muscle and joint pain.
I have or had a muscle or nerve condition.
I use a baclofen pump for muscle stiffness.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessments of neurological status, force generation, and independence

6 weeks
2 visits (in-person)

Treatment

Participants receive spinal neuromodulation therapy using TSS and ESS

5 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Epidural Spinal Stimulation (ESS)
  • Transcutaneous Spinal cord Stimulation
Trial Overview The trial tests how non-invasive spinal stimulation techniques—Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal cord Stimulation (TSS)—can help people regain standing ability after complete motor paralysis from spinal cord injury. It explores the electrical mechanisms of these treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Epidural Spinal Stimulation (ESS)Experimental Treatment1 Intervention
Group II: Transcutaneous Spinal Stimulation (TSS)Active Control1 Intervention
Group III: ShamPlacebo Group1 Intervention

Epidural Spinal Stimulation (ESS) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Epidural Spinal Stimulation (ESS) for:
🇺🇸
Approved in United States as Epidural Spinal Stimulation (ESS) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

Epidural spinal electrostimulation (ESES) has shown promising results in improving spinal spasticity and mobility by 20 to 30% in patients with multiple sclerosis and myelopathy, indicating its efficacy in treating severe central motor disturbances.
In addition to mobility improvements, ESES led to a complete disappearance of spastic cramps in all treated cases and significant pain relief in three patients with chronic pain, suggesting its potential as a non-surgical intervention for chronic pain management.
[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)].Klingler, D., Kepplinger, B., Gerstenbrand, F., et al.[2006]
Epidural electrical spinal cord stimulation (ESCS) has shown promise not only in managing chronic pain but also in partially restoring motor function and neurological recovery in patients with spinal cord injuries, particularly when combined with rehabilitative therapies.
ESCS is also being explored for treating autonomic dysfunctions, such as orthostatic hypotension, indicating its potential to become a routine therapy for various complications following spinal cord injuries.
Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury.Luz, A., Rupp, R., Ahmadi, R., et al.[2023]
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.
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]

Citations

Epidural electrical stimulation for spinal cord injury - PMCIn multiple animal models of spinal cord injury, epidural electrical stimulation of the spinal cord has demonstrated a recovery of motor function.
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 ...
Non-invasive spinal cord electrical stimulation for arm and ...These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.
Epidural electrical stimulation facilitates motor recovery in ...Recent studies have shown that epidural electrical stimulation (EES), combined with tailored rehabilitation, can restore lower limb motor function after SCI.
Effect of epidural spinal cord stimulation after chronic spinal ...The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.
Epidural Electrical Stimulation in Spinal Cord InjuryThe goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security