Stimulation-based Therapy to Improve Balance in DCM

Official title

Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy

Overview

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.

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 tas
• Other Balance and Gait Training
  Structured balance and gait training will be performed for the participant.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• 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 [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Sensory Organization Test (SOT) - Somatosensory and Vestibular Score [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Single-Leg Stance Time [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Functional Gait Assessment (FGA) [Time frame: From enrollment to the end of the intervention at 4 weeks]
• 6-Meter Walk Test Gait Speed [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Timed Up and Go (TUG) [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Responder Status (MCID Achievement) [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Modified Japanese Orthopaedic Association (mJOA) Score [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Neck Disability Index (NDI) [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Numeric Rating Scale (NRS) for Pain [Time frame: From enrollment to the end of the intervention at 4 weeks]
• SF-36 Physical Component Score (PCS) [Time frame: From enrollment to the end of the intervention at 4 weeks]
• Clinician Global Impression of Change (CGIC) [Time frame: From enrollment to the end of the intervention at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Marquette University — Milwaukee

Identifiers

NCT: NCT07298460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗