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

Medical College of Wisconsin

Status and phase: Begins enrollment in 4 months; Phase 2; Phase 1

Conditions: Degenerative Cervical Myelopathy

Treatments: Other: Balance and Gait Training; Device: Transcutaneous spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifier

NCT07298460

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Thoracic tSCS + balance training

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous spinal cord stimulation

Other: Balance and Gait Training

Combined cervical and thoracic tSCS + balance training

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous spinal cord stimulation

Other: Balance and Gait Training

Sham tSCS + balance training

Sham Comparator group

Description:

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.

Treatment:

Other: Balance and Gait Training