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NCT Number: NCT07298460

Stimulation-based Therapy to Improve Balance in DCM

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.

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Key information

Conditions

Degenerative Cervical Myelopathy

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Balance and Gait Training

Other

Structured balance and gait training will be performed for the participant.

Primary outcomes

  1. 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.

  2. 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.

Secondary 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

    Time frame: 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.

  2. Sensory Organization Test (SOT) - Somatosensory and Vestibular Score

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Quantifies reliance on somatosensory and vestibular input for balance under altered sensory conditions.

  3. Single-Leg Stance Time

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Duration of stable single-leg standing, assessing unilateral static balance capacity.

  4. Functional Gait Assessment (FGA)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Performance-based measure of dynamic balance during complex walking tasks.

  5. 6-Meter Walk Test Gait Speed

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Average walking speed over a short distance, reflecting functional mobility and gait efficiency.

  6. Timed Up and Go (TUG)

    Time frame: 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.

  7. Responder Status (MCID Achievement)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Proportion of participants achieving a minimum clinically important improvement in predefined outcomes.

  8. Modified Japanese Orthopaedic Association (mJOA) Score

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Clinician-rated measure of neurological function in cervical myelopathy.

  9. Neck Disability Index (NDI)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Patient-reported measure of neck-related functional disability.

  10. Numeric Rating Scale (NRS) for Pain

    Time frame: 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.

  11. SF-36 Physical Component Score (PCS)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Generic health-related quality-of-life measure focused on physical functioning.

  12. Clinician Global Impression of Change (CGIC)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Clinician-rated assessment of overall change in patient condition.

  13. Patient Global Impression of Change (PGIC)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Patient-reported perception of overall improvement or worsening.

  14. Fall Frequency

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Number of self-reported falls recorded prospectively in a fall diary.

  15. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Incidence and severity of treatment-emergent adverse and serious adverse events.

  16. Lower-Extremity Somatosensory Evoked Potential (SSEP) Latencies

    Time frame: 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.

  17. Motor Evoked Potentials (MEPs) - Tibialis Anterior and Abductor Pollicis Brevis

    Time frame: From enrollment to the end of the intervention at 4 weeks

    Evoked motor responses assessing corticospinal tract excitability and conduction to the lower extremities.

  18. Surface EMG Amplitude - Tibialis Anterior and Quadriceps

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Advancing a Healthier Wisconsin Endowment
  • Froedtert Hospital
  • Marquette University

Registry information

Official study title

Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy

Acronym: STIM-DCM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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