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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
Structured balance and gait training will be performed for the participant.
Marquette University
Milwaukee, Wisconsin, United States
Berg Balance Scale
The Berg Balance Scale is a validated clinical measure of static and dynamic balance.
Time frame: 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.
Time frame: From enrollment to the end of the intervention at 4 weeks
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.
Time frame: From enrollment to the end of the intervention at 4 weeks
Sensory Organization Test (SOT) - Somatosensory and Vestibular Score
Quantifies reliance on somatosensory and vestibular input for balance under altered sensory conditions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the intervention at 4 weeks
Neck Disability Index (NDI)
Patient-reported measure of neck-related functional disability.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the intervention at 4 weeks
Fall Frequency
Number of self-reported falls recorded prospectively in a fall diary.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the intervention at 4 weeks
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