Stimulation-based Therapy to Improve Balance in DCM

NCT07298460 | Not Yet Recruiting Phase 1 FDA Device

• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Degenerative Cervical Myelopathy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 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

  From enrollment to the end of the intervention at 4 weeks

• Sensory Organization Test (SOT) - Somatosensory and Vestibular Score

  From enrollment to the end of the intervention at 4 weeks

• Single-Leg Stance Time

  From enrollment to the end of the intervention at 4 weeks

• Functional Gait Assessment (FGA)

  From enrollment to the end of the intervention at 4 weeks

• 6-Meter Walk Test Gait Speed

  From enrollment to the end of the intervention at 4 weeks

Study Arms (3)

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.

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.

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.

Other: Balance and Gait Training

Interventions

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.

Combined cervical and thoracic tSCS + balance training; Thoracic tSCS + balance training

Balance and Gait Training OTHER

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

Combined cervical and thoracic tSCS + balance training; Sham tSCS + balance training; Thoracic tSCS + balance training

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator
• Advancing a Healthier Wisconsin Endowment: collaborator
• Froedtert Hospital: collaborator

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)