Recruiting
Phase 1
Phase 2

tSCS & Balance Training

Sponsor:

Medical College of Wisconsin

Code:

NCT07298460

Conditions

Degenerative Cervical Myelopathy

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous spinal cord stimulation

Balance and Gait Training

Study Details

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:

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

Study ID

NCT07298460

Start date

Dec 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Balance and Gait Training

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

Primary outcome measure

  • Berg Balance Scale [ Time Frame: From enrollment to the end of the intervention at 4 weeks ]
  • Motor evoked potential (MEP) amplitude in the quadriceps of either leg [ Time Frame: From enrollment to the end of the intervention at 4 weeks ]

Central Contacts and Locations

Locations

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Brian D Schmit, PhD

414-288-6125brian.schmit@marquette.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.