Stimulation-based Therapy to Improve Balance in DCM (STIM-DCM)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Degenerative Cervical Myelopathy
• Intervention / Treatment: Device: Transcutaneous spinal cord stimulation; Other: Balance and Gait Training

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Marquette University
      • Contact: Brian D Schmit, PhD; Phone Number: (414) 288-6125; Email: brian.schmit@marquette.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic tSCS + balance training; 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.	Device: Transcutaneous spinal cord stimulation; 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.; Other: Balance and Gait Training; Structured balance and gait training will be performed for the participant.
Active Comparator: Combined cervical and thoracic tSCS + balance training; 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.	Device: Transcutaneous spinal cord stimulation; 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.; Other: Balance and Gait Training; Structured balance and gait training will be performed for the participant.
Sham Comparator: Sham tSCS + balance training; 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.	Other: Balance and Gait Training; Structured balance and gait training will be performed for the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Marquette University; Froedtert Hospital; Advancing a Healthier Wisconsin Endowment

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; spinal cord stimulation; balance; therapy; postural instability; degenerative cervical myelopathy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No