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| Name | Class |
|---|---|
| Marquette University | OTHER |
| Advancing a Healthier Wisconsin Endowment | OTHER |
| Froedtert Hospital | OTHER |
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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:
What will happen in this study:
Participants will be randomly assigned to one of three groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic tSCS + balance training | Active Comparator | 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. |
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| Combined cervical and thoracic tSCS + balance training | Active Comparator | 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. |
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| Sham tSCS + balance training | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal cord stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | The Berg Balance Scale is a validated clinical measure of static and dynamic balance. | From enrollment to the end of the intervention at 4 weeks |
| Motor evoked potential (MEP) amplitude in the quadriceps of either leg | 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. | From enrollment to the end of the intervention at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Total displacement of the center of pressure during quiet standing with eyes closed on firm and foam surfaces, reflecting postural sway magnitude. | From enrollment to the end of the intervention at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marquette University | Milwaukee | Wisconsin | 53233 | United States |
Individual participant data that underlie the results reported in this study will not be shared publicly. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to approval by the institutional review board and execution of a data use agreement.
De-identified individual participant data will be available after publication of the primary results and for up a particular duration thereafter. This time period will be determine by the IRB and data use agreement.
De-identified individual participant data and supporting documentation (including the study protocol and statistical analysis plan) will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound research proposal and will be reviewed by the study investigators. Access will be granted following institutional review board approval, as applicable, and execution of a data use agreement. Data will be provided through a secure data-sharing mechanism.
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| Balance and Gait Training | Other | Structured balance and gait training will be performed for the participant. |
|
| Sensory Organization Test (SOT) - Somatosensory and Vestibular Score | Quantifies reliance on somatosensory and vestibular input for balance under altered sensory conditions. | From enrollment to the end of the intervention at 4 weeks |
| Single-Leg Stance Time | Duration of stable single-leg standing, assessing unilateral static balance capacity. | From enrollment to the end of the intervention at 4 weeks |
| Functional Gait Assessment (FGA) | Performance-based measure of dynamic balance during complex walking tasks. | From enrollment to the end of the intervention at 4 weeks |
| 6-Meter Walk Test Gait Speed | Average walking speed over a short distance, reflecting functional mobility and gait efficiency. | From enrollment to the end of the intervention at 4 weeks |
| Timed Up and Go (TUG) | Time required to stand, walk, turn, and sit, capturing functional mobility and fall risk. | From enrollment to the end of the intervention at 4 weeks |
| Responder Status (MCID Achievement) | Proportion of participants achieving a minimum clinically important improvement in predefined outcomes. | From enrollment to the end of the intervention at 4 weeks |
| Modified Japanese Orthopaedic Association (mJOA) Score | Clinician-rated measure of neurological function in cervical myelopathy. | From enrollment to the end of the intervention at 4 weeks |
| Neck Disability Index (NDI) | Patient-reported measure of neck-related functional disability. | From enrollment to the end of the intervention at 4 weeks |
| Numeric Rating Scale (NRS) for Pain | Patient-reported pain intensity for neck, arm, leg, and device-related pain on a 0-10 scale. | From enrollment to the end of the intervention at 4 weeks |
| SF-36 Physical Component Score (PCS) | Generic health-related quality-of-life measure focused on physical functioning. | From enrollment to the end of the intervention at 4 weeks |
| Clinician Global Impression of Change (CGIC) | Clinician-rated assessment of overall change in patient condition. | From enrollment to the end of the intervention at 4 weeks |
| Patient Global Impression of Change (PGIC) | Patient-reported perception of overall improvement or worsening. | From enrollment to the end of the intervention at 4 weeks |
| Fall Frequency | Number of self-reported falls recorded prospectively in a fall diary. | From enrollment to the end of the intervention at 4 weeks |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and severity of treatment-emergent adverse and serious adverse events. | From enrollment to the end of the intervention at 4 weeks |
| Lower-Extremity Somatosensory Evoked Potential (SSEP) Latencies | Cortical response latencies following peripheral stimulation, reflecting integrity and conduction efficiency of ascending somatosensory pathways. | From enrollment to the end of the intervention at 4 weeks |
| Motor Evoked Potentials (MEPs) - Tibialis Anterior and Abductor Pollicis Brevis | Evoked motor responses assessing corticospinal tract excitability and conduction to the lower extremities. | From enrollment to the end of the intervention at 4 weeks |
| Surface EMG Amplitude - Tibialis Anterior and Quadriceps | Magnitude of muscle activation during stimulation, indexing neuromuscular recruitment of ankle dorsiflexors and knee extensors. | From enrollment to the end of the intervention at 4 weeks |