Stimulation-based Therapy to Improve Balance in DCM

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:

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.

Conditions

• Degenerative Cervical Myelopathy

Interventions

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.

Sponsors & Collaborators

• Marquette University

  collaborator OTHER

• Advancing a Healthier Wisconsin Endowment

  collaborator UNKNOWN

• Froedtert Hospital

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-07-01

Completion

2028-07-01

FDA Device

Yes

Countries

• United States

Study Locations