Spinal Cord Stimulation + Balance Training for Cervical Spinal Stenosis
(STIM-DCM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether transcutaneous spinal cord stimulation (tSCS), combined with balance training, can improve balance in individuals after surgery for degenerative cervical myelopathy (DCM), a condition affecting walking and balance. Participants will join one of three groups: one receiving stimulation to the mid-back, another receiving stimulation to both the neck and mid-back, and a third receiving a placebo treatment. All groups will undergo balance training. The study aims to determine if this combination is more effective than balance training alone and will also examine changes in nerve and muscle activity. Individuals who had surgery for DCM over a year ago and still experience balance issues may be suitable for this study. As a Phase 1, Phase 2 trial, the study focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that transcutaneous spinal cord stimulation is safe for improving balance in adults with cervical spinal stenosis?
Research shows that transcutaneous spinal cord stimulation (tSCS) is generally safe. In past studies, participants experienced very few side effects after receiving tSCS. For instance, thirty sessions of this non-invasive spinal cord treatment were well-tolerated by individuals with various spinal issues.
Additionally, studies on tSCS applied to both the neck and mid-back areas have found it safe and effective for improving movement. Participants did not report any major concerning side effects.
While specific data on side effects for this trial is not yet available, earlier research suggests that the treatment is promising. However, since this trial is in the early stages, monitoring for any possible side effects remains crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cervical spinal stenosis because they combine a novel approach with traditional balance training to improve outcomes for patients with degenerative cervical myelopathy (DCM). Unlike the standard surgical decompression, which focuses on relieving pressure on the spinal cord, these treatments use transcutaneous spinal cord stimulation (tSCS) — a noninvasive technique that stimulates the spinal cord through the skin. The Thoracic tSCS and the Combined cervical and thoracic tSCS approaches aim to enhance neural pathways, potentially improving balance and mobility more effectively than existing methods. Additionally, the use of a sham tSCS group helps to ensure that any observed benefits are due to the stimulation itself and not just the balance training.
What evidence suggests that this trial's treatments could be effective for improving balance in adults with degenerative cervical myelopathy?
Research has shown that transcutaneous spinal cord stimulation (tSCS) can improve balance in individuals with spinal cord issues. In previous studies, participants with spinal cord injuries experienced better balance after tSCS sessions. This suggests the therapy might also benefit those with degenerative cervical myelopathy (DCM) in maintaining balance post-surgery. This trial tests both thoracic tSCS and combined cervical-thoracic tSCS to determine which is more effective. Participants will receive either thoracic tSCS or combined cervical-thoracic tSCS, each paired with balance training, to assess their effectiveness. Combining balance exercises with tSCS could significantly enhance balance and walking skills in these patients.12467
Are You a Good Fit for This Trial?
This trial is for adults who've had surgery over a year ago for degenerative cervical myelopathy (DCM) but still have balance issues. It's not suitable for those with certain conditions that the study doesn't specify.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transcutaneous spinal cord stimulation (tSCS) combined with balance training or sham stimulation over 12 sessions in 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous spinal cord stimulation
Trial Overview
The study tests if transcutaneous spinal cord stimulation (tSCS), combined with balance training, improves balance in DCM patients better than just balance training. Participants are randomly placed into three groups to compare different tSCS applications or sham treatment.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
This intervention combines noninvasive thoracic transcutaneous spinal cord stimulation (tSCS) with a structured balance training program specifically for adults with degenerative cervical myelopathy (DCM) who have undergone surgical decompression but continue to experience impaired balance.
This intervention combines noninvasive combined cervical and thoracic transcutaneous spinal cord stimulation (tSCS) with a structured balance training program specifically for adults with degenerative cervical myelopathy (DCM) who have undergone surgical decompression but continue to experience impaired balance.
This intervention combines sham transcutaneous spinal cord stimulation (tSCS) with a structured balance training program specifically for adults with degenerative cervical myelopathy (DCM) who have undergone surgical decompression but continue to experience impaired balance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Marquette University
Collaborator
Advancing a Healthier Wisconsin Endowment
Collaborator
Froedtert Hospital
Collaborator
Citations
Stimulation-based Therapy to Improve Balance in DCM
Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy. Conditions.
Spinal Cord Stimulation + Balance Training for Cervical ...
This trial is for adults who've had surgery over a year ago for degenerative cervical myelopathy (DCM) but still have balance issues. It's not suitable for ...
Multi-system benefits of non-invasive spinal cord stimulation ...
Thirty sessions of non-invasive spinal cord stimulation targeting the lumbosacral spinal cord were tolerated well in an individual with chronic ...
Transcutaneous spinal cord stimulation and Balance and Gait ...
Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy. The goal of this ...
Degenerative Cervical Myelopathy in a Patient With a Pre- ...
The SCS was providing relief for severe, debilitating chronic regional pain syndrome. As such, the patient expressed she would prefer to retain ...
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clinicaltrial.be
clinicaltrial.be/en/details/443774?per_page=20&only_recruiting=0&only_eligible=0&only_active=0Evaluating Safety and Feasibility of Transcutaneous Spina...
Degenerative cervical myelopathy (DCM) represents the most ... The use of transcutaneous spinal cord stimulation (Tc-SCS) in chronic SCI ...
Safety and Feasibility of Cervical and Thoracic ...
Safety and Feasibility of Cervical and Thoracic Transcutaneous Spinal Cord Stimulation to Improve Hand Motor Function in Children With Chronic ...
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