Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2026-07-01
2028-07-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thoracic tSCS + balance training
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.
Transcutaneous spinal cord stimulation
This intervention combines noninvasive 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. Unlike standard physical therapy or other neuromodulation approaches, this protocol uses targeted stimulation sites and parameters-thoracic-only or combined cervico-thoracic stimulation-delivered concurrently with task-specific balance and gait training to enhance neuromotor recovery. The stimulation is applied using a Chattanooga Vectra device at tolerable intensity, integrated into 12 sessions over 4 weeks. This design uniquely addresses persistent postural instability in post-surgical DCM.
Balance and Gait Training
Structured balance and gait training will be performed for the participant.
Combined cervical and thoracic tSCS + balance training
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.
Transcutaneous spinal cord stimulation
This intervention combines noninvasive 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. Unlike standard physical therapy or other neuromodulation approaches, this protocol uses targeted stimulation sites and parameters-thoracic-only or combined cervico-thoracic stimulation-delivered concurrently with task-specific balance and gait training to enhance neuromotor recovery. The stimulation is applied using a Chattanooga Vectra device at tolerable intensity, integrated into 12 sessions over 4 weeks. This design uniquely addresses persistent postural instability in post-surgical DCM.
Balance and Gait Training
Structured balance and gait training will be performed for the participant.
Sham tSCS + balance training
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.
Balance and Gait Training
Structured balance and gait training will be performed for the participant.
Interventions
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Transcutaneous spinal cord stimulation
This intervention combines noninvasive 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. Unlike standard physical therapy or other neuromodulation approaches, this protocol uses targeted stimulation sites and parameters-thoracic-only or combined cervico-thoracic stimulation-delivered concurrently with task-specific balance and gait training to enhance neuromotor recovery. The stimulation is applied using a Chattanooga Vectra device at tolerable intensity, integrated into 12 sessions over 4 weeks. This design uniquely addresses persistent postural instability in post-surgical DCM.
Balance and Gait Training
Structured balance and gait training will be performed for the participant.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
90 Years
ALL
No
Sponsors
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Marquette University
OTHER
Advancing a Healthier Wisconsin Endowment
UNKNOWN
Froedtert Hospital
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Aditya Vedantam
Associate Professor
Locations
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Marquette University
Milwaukee, Wisconsin, United States
Countries
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Facility Contacts
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Brian D Schmit, PhD
Role: primary