Spinal Cord Stimulation for Spinal Cord Injury
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Initial assessments of neurological status, force generation, and independence
Treatment
Participants receive spinal neuromodulation therapy using TSS and ESS
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epidural Spinal Stimulation (ESS)
- Transcutaneous Spinal cord Stimulation
Epidural Spinal Stimulation (ESS) is already approved in European Union, United States for the following indications:
- Chronic pain
- Failed back surgery syndrome
- Complex regional pain syndrome
- Intractable angina
- Visceral abdominal and perineal pain
- Pain in the extremities from nerve damage
- Chronic pain
- Failed back surgery syndrome
- Complex regional pain syndrome
- Intractable angina
- Visceral abdominal and perineal pain
- Pain in the extremities from nerve damage
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator