NCT07298460 Stimulation-based Therapy to Improve Balance in DCM
| NCT ID | NCT07298460 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Medical College of Wisconsin |
| Condition | Degenerative Cervical Myelopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-12-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2026-12-01 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine if a treatment called transcutaneous spinal cord stimulation (tSCS), when combined with balance training, can help improve balance in adults who have had surgery for degenerative cervical myelopathy (DCM). DCM is a condition that affects the spinal cord in the neck and often causes problems with walking and balance, even after surgery. This study will also look at how tSCS affects the nervous system and whether it is safe and practical to use in this group of patients. The results will help researchers plan a larger study in the future. Main Questions: * Does tSCS combined with balance training improve balance more than balance training alone? * Does stimulation at both the neck and mid-back work better than stimulation at the mid-back only? * What changes in nerve and muscle activity occur with tSCS? What will happen in this study: * Participants will be randomly assigned to one of three groups: 1. tSCS applied to the mid-back (thoracic area) plus balance training 2. tSCS applied to both the neck and mid-back (combined stimulation) plus balance training 3. Sham stimulation (electrodes placed but no stimulation) plus balance training * All participants will complete 12 sessions over 4 weeks (3 sessions per week). * Each session will include 30 minutes of balance training and 30 minutes of walking exercises. * Participants will receive stimulation or sham treatment during these sessions. * Balance and walking tests will be done before and after the program. * Nerve and muscle activity will also be measured at the same time points. This pilot study will help determine if tSCS is effective and safe, and will provide information needed to design a larger trial.
Eligibility Criteria
Inclusion Criteria: * DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance Exclusion Criteria: * uncontrolled cardiopulmonary disease, legal blindness, unstable medical condition that can interfere with the study, breakdown in skin area that will come into contact with electrodes, active implanted medical device, pregnancy, and seizures * concurrent occupational or physical therapy during study participation for any condition * history of inability to tolerate MEP/SSEP for any reason, or complete paralysis of the legs (lower limb mJOA=0) * cognitive impairment and unable to give consent
Frequently Asked Questions
Who can join the NCT07298460 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Degenerative Cervical Myelopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07298460 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07298460 currently recruiting?
Yes, NCT07298460 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical College of Wisconsin to inquire about joining.
Where is the NCT07298460 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT07298460 clinical trial?
NCT07298460 is sponsored by Medical College of Wisconsin. The trial plans to enroll 45 participants.