Degenerative Cervical Myelopathy
Conditions
Keywords
degenerative cervical myelopathy, spinal cord stimulation, balance, therapy, rehabilitation, postural instability
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.
Interventions
DEVICETranscutaneous 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.
OTHERBalance and Gait Training
Structured balance and gait training will be performed for the participant.
Sponsors
Marquette University
Advancing a Healthier Wisconsin Endowment
Froedtert Hospital
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | From enrollment to the end of the intervention at 4 weeks | The Berg Balance Scale is a validated clinical measure of static and dynamic balance. |
| Motor evoked potential (MEP) amplitude in the quadriceps of either leg | From enrollment to the end of the intervention at 4 weeks | Motor evoked potential (MEP) amplitude recorded from the quadriceps to assess changes in corticospinal excitability when comparing combined cervico-thoracic tSCS versus thoracic-only tSCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single-Leg Stance Time | From enrollment to the end of the intervention at 4 weeks | Duration of stable single-leg standing, assessing unilateral static balance capacity. |
| Functional Gait Assessment (FGA) | From enrollment to the end of the intervention at 4 weeks | Performance-based measure of dynamic balance during complex walking tasks. |
| 6-Meter Walk Test Gait Speed | From enrollment to the end of the intervention at 4 weeks | Average walking speed over a short distance, reflecting functional mobility and gait efficiency. |
| Timed Up and Go (TUG) | From enrollment to the end of the intervention at 4 weeks | Time required to stand, walk, turn, and sit, capturing functional mobility and fall risk. |
| Responder Status (MCID Achievement) | From enrollment to the end of the intervention at 4 weeks | Proportion of participants achieving a minimum clinically important improvement in predefined outcomes. |
| Modified Japanese Orthopaedic Association (mJOA) Score | From enrollment to the end of the intervention at 4 weeks | Clinician-rated measure of neurological function in cervical myelopathy. |
| Neck Disability Index (NDI) | From enrollment to the end of the intervention at 4 weeks | Patient-reported measure of neck-related functional disability. |
| Numeric Rating Scale (NRS) for Pain | From enrollment to the end of the intervention at 4 weeks | Patient-reported pain intensity for neck, arm, leg, and device-related pain on a 0-10 scale. |
| Center of pressure (CoP) path length and mean velocity during the modified Clinical Test of Sensory Integration for Balance (mCTSIB) with eyes closed on firm and foam surfaces | From enrollment to the end of the intervention at 4 weeks | Total displacement of the center of pressure during quiet standing with eyes closed on firm and foam surfaces, reflecting postural sway magnitude. |
| Clinician Global Impression of Change (CGIC) | From enrollment to the end of the intervention at 4 weeks | Clinician-rated assessment of overall change in patient condition. |
| Patient Global Impression of Change (PGIC) | From enrollment to the end of the intervention at 4 weeks | Patient-reported perception of overall improvement or worsening. |
| Fall Frequency | From enrollment to the end of the intervention at 4 weeks | Number of self-reported falls recorded prospectively in a fall diary. |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | From enrollment to the end of the intervention at 4 weeks | Incidence and severity of treatment-emergent adverse and serious adverse events. |
| Lower-Extremity Somatosensory Evoked Potential (SSEP) Latencies | From enrollment to the end of the intervention at 4 weeks | Cortical response latencies following peripheral stimulation, reflecting integrity and conduction efficiency of ascending somatosensory pathways. |
| Motor Evoked Potentials (MEPs) - Tibialis Anterior and Abductor Pollicis Brevis | From enrollment to the end of the intervention at 4 weeks | Evoked motor responses assessing corticospinal tract excitability and conduction to the lower extremities. |
| Surface EMG Amplitude - Tibialis Anterior and Quadriceps | From enrollment to the end of the intervention at 4 weeks | Magnitude of muscle activation during stimulation, indexing neuromuscular recruitment of ankle dorsiflexors and knee extensors. |
| SF-36 Physical Component Score (PCS) | From enrollment to the end of the intervention at 4 weeks | Generic health-related quality-of-life measure focused on physical functioning. |
| Sensory Organization Test (SOT) - Somatosensory and Vestibular Score | From enrollment to the end of the intervention at 4 weeks | Quantifies reliance on somatosensory and vestibular input for balance under altered sensory conditions. |
Countries
United States
Outcome results
None listed