Stimulation-based Therapy to Improve Balance in DCM
ConditionDegenerative Cervical Myelopathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorMedical College of Wisconsin
About this trial
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
This trial does not accept healthy volunteersQualifiers
DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous spinal cord stimulation
DeviceThis 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
Other interventionStructured balance and gait training will be performed for the participant.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Thoracic tSCS + balance trainingActive comparator 2 interventions
Group B: Combined cervical and thoracic tSCS + balance trainingActive comparator 2 interventions
Group C: Sham tSCS + balance trainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical College of Wisconsin
Lead sponsor
Marquette University
Collaborator
Advancing a Healthier Wisconsin Endowment
Collaborator
Froedtert Hospital
Collaborator
Source ClinicalTrials.gov
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