A randomized controlled trial to evaluate the effect of intermittent theta burst stimulation on gait pathomechanics and urinary tract dysfunction in incomplete spinal cord injury patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc)
研究概览
简要总结
Spinal cord injury is a serious condition that produce significant impairment in motor, sensory and autonomic functions. To manage spinal cord injury conventional treatment have been employed such as: pharmacological, surgical and rehabilitation etc., few novel treatment strategies are under investigation to expect a better recovery. Intermittent theta burst stimulation is one of such non-invasive neuromodulation technique. Impaired gait and neurogenic bladder are major consequences of spinal cord injury with fatal outcome but less commonly addressed in previous literature. We hypothesize that cortical application of intermittent theta burst stimulation will improve gait pathomechanics and neurogenic lower urinary tract dysfunction in incomplete spinal cord injury patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Spinal cord Injury (ASIA C or D) Region: (Cervical C6 and C7), Thoracic and Lumbar Spine Duration : ≤ 2 years Type: Traumatic and Non-traumatic.
排除标准
- •Osteoporotic fractures, or other Pathological fractures.
- •History of neurological or orthopaedic disease related to spinal cord.
- •Congenital malformations (disorder of neuro lesions) pertaining to CNS or PNS.
- •Cardiac Pacemaker, DBS, spinal cord stimulator, baclofen pump or any ferromagnetic metallic implants close to the target stimulation area.
- •Ventilator dependent and tracheostomy patients.
- •Cognitive impairments.
- •History/family history of seizures.
- •Acute eczema/ bed sore under the target stimulation area.
结局指标
主要结局
Spatio- Temporal parameters of Gait (Walking speed, Stride length, Cadence etc)
时间窗: Baseline and 4 weeks after completion of the intervention
次要结局
- Urodynamic parameters (Detrusor leak point pressure, Detrusor sphincter dyssynergia, Incontinence abdominal leak point pressure, Post-void residual volume etc.).(Electrophysiological parameters (Resting Motor Threshold, Active Motor Threshold, Motor Evoked Potential).)