Transcutaneous Spinal Cord Stimulation to Improve Postural Stability After Surgery for Degenerative Cervical Myelopathy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DCM participants who have undergone surgery for DCM more than 12 months prior and report persistent impaired imbalance
排除标准
- •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
结局指标
主要结局
Berg Balance Scale
时间窗: From enrollment to the end of the intervention at 4 weeks
The Berg Balance Scale is a validated clinical measure of static and dynamic balance.
Motor evoked potential (MEP) amplitude in the quadriceps of either leg
时间窗: From enrollment to the end of the intervention at 4 weeks
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.
次要结局
- 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)
- Timed Up and Go (TUG)(From enrollment to the end of the intervention at 4 weeks)
- Responder Status (MCID Achievement)(From enrollment to the end of the intervention at 4 weeks)
- Modified Japanese Orthopaedic Association (mJOA) Score(From enrollment to the end of the intervention at 4 weeks)
- Neck Disability Index (NDI)(From enrollment to the end of the intervention at 4 weeks)
- Numeric Rating Scale (NRS) for Pain(From enrollment to the end of the intervention at 4 weeks)
- SF-36 Physical Component Score (PCS)(From enrollment to the end of the intervention at 4 weeks)
- Clinician Global Impression of Change (CGIC)(From enrollment to the end of the intervention at 4 weeks)
- Patient Global Impression of Change (PGIC)(From enrollment to the end of the intervention at 4 weeks)
- Fall Frequency(From enrollment to the end of the intervention at 4 weeks)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(From enrollment to the end of the intervention at 4 weeks)
- Lower-Extremity Somatosensory Evoked Potential (SSEP) Latencies(From enrollment to the end of the intervention at 4 weeks)
- Motor Evoked Potentials (MEPs) - Tibialis Anterior and Abductor Pollicis Brevis(From enrollment to the end of the intervention at 4 weeks)
- Surface EMG Amplitude - Tibialis Anterior and Quadriceps(From enrollment to the end of the intervention at 4 weeks)
研究者
Aditya Vedantam
Associate Professor
Medical College of Wisconsin