Degenerative Cervical MyelopathyPhase 1/2STIM-DCMNCT07298460
Stimulation-based Therapy to Improve Balance in DCM
A Phase 1/2 study testing Transcutaneous spinal cord stimulation and Balance and Gait Training in people with Degenerative Cervical Myelopathy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Degenerative Cervical Myelopathy
- What is being tested?
- Transcutaneous spinal cord stimulation and Balance and Gait Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Marquette University
Milwaukee, Wisconsin, 53233
Brian D Schmit, PhD, (414) 288-6125, brian.schmit@marquette.edu
About this study
Official title: Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy
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.
Read more
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:
- tSCS applied to the mid-back (thoracic area) plus balance training
- tSCS applied to both the neck and mid-back (combined stimulation) plus balance training
- 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.
- Conditions
- Degenerative Cervical Myelopathy
- Being tested
- Transcutaneous spinal cord stimulation, Balance and Gait Training
- Keywords
- degenerative cervical myelopathy, spinal cord stimulation, balance, therapy, rehabilitation, postural instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulationDevice
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 TrainingOther
Structured balance and gait training will be performed for the participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous spinal cord stimulation; Other: Balance and Gait Training |
| 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. Receives: Device: Transcutaneous spinal cord stimulation; Other: Balance and Gait Training |
| 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. Receives: Other: Balance and Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale is a validated clinical measure of static and dynamic balance.
Measured: 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.
Measured: From enrollment to the end of the intervention at 4 weeks
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 4 weeks
Neck Disability Index (NDI)
Patient-reported measure of neck-related functional disability.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 4 weeks
Fall Frequency
Number of self-reported falls recorded prospectively in a fall diary.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, Advancing a Healthier Wisconsin Endowment, Froedtert Hospital
- Responsible party
- Principal investigator, Aditya Vedantam, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298460
- Acronym
- STIM-DCM
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy
- ClinicalTrials.gov ID
- NCT07298460
- Acronym / sponsor ID
- STIM-DCM
- Conditions
- Degenerative Cervical Myelopathy
- Keywords
- degenerative cervical myelopathy, spinal cord stimulation, balance, therapy, rehabilitation, postural instability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University, Advancing a Healthier Wisconsin Endowment, Froedtert Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- tSCS applied to the mid-back (thoracic area) plus balance training
- tSCS applied to both the neck and mid-back (combined stimulation) plus balance training
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic tSCS + balance training | Active comparator | Device: Transcutaneous spinal cord stimulation, Other: Balance and Gait TrainingThis 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. |
| Combined cervical and thoracic tSCS + balance training | Active comparator | Device: Transcutaneous spinal cord stimulation, Other: Balance and Gait TrainingThis 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. |
| Sham tSCS + balance training | Sham comparator | Other: Balance and Gait TrainingThis 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulationThis 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. | Device | Combined cervical and thoracic tSCS + balance training, Thoracic tSCS + balance training |
| Balance and Gait TrainingStructured balance and gait training will be performed for the participant. | Other | Combined cervical and thoracic tSCS + balance training, Sham tSCS + balance training, Thoracic tSCS + balance training |
Primary outcome
Berg Balance Scale
Time frame: 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
Time frame: 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.
18 secondary outcomes
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
Time frame: From enrollment to the end of the intervention at 4 weeks
Sensory Organization Test (SOT) - Somatosensory and Vestibular Score
Time frame: From enrollment to the end of the intervention at 4 weeks
Single-Leg Stance Time
Time frame: From enrollment to the end of the intervention at 4 weeks
Functional Gait Assessment (FGA)
Time frame: From enrollment to the end of the intervention at 4 weeks
6-Meter Walk Test Gait Speed
Time frame: From enrollment to the end of the intervention at 4 weeks
Timed Up and Go (TUG)
Time frame: From enrollment to the end of the intervention at 4 weeks
Responder Status (MCID Achievement)
Time frame: From enrollment to the end of the intervention at 4 weeks
Modified Japanese Orthopaedic Association (mJOA) Score
Time frame: From enrollment to the end of the intervention at 4 weeks
Neck Disability Index (NDI)
Time frame: From enrollment to the end of the intervention at 4 weeks
Numeric Rating Scale (NRS) for Pain
Time frame: From enrollment to the end of the intervention at 4 weeks
SF-36 Physical Component Score (PCS)
Time frame: From enrollment to the end of the intervention at 4 weeks
Clinician Global Impression of Change (CGIC)
Time frame: From enrollment to the end of the intervention at 4 weeks
Patient Global Impression of Change (PGIC)
Time frame: From enrollment to the end of the intervention at 4 weeks
Fall Frequency
Time frame: From enrollment to the end of the intervention at 4 weeks
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrollment to the end of the intervention at 4 weeks
Lower-Extremity Somatosensory Evoked Potential (SSEP) Latencies
Time frame: From enrollment to the end of the intervention at 4 weeks
Motor Evoked Potentials (MEPs) - Tibialis Anterior and Abductor Pollicis Brevis
Time frame: From enrollment to the end of the intervention at 4 weeks
Surface EMG Amplitude - Tibialis Anterior and Quadriceps
Time frame: From enrollment to the end of the intervention at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous spinal cord stimulation and Balance and Gait Training in people with Degenerative Cervical Myelopathy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: From enrollment to the end of the intervention at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.