Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of participants with morbidity as measured by infections
研究概览
简要总结
The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.
详细描述
Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity. Gaps in the knowledge which we intend to fill are:
- Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.
- Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months.
- Analysis of neuropathic pain medication dosages in those with and without TINS at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study participants will be blinded to the stimulation parameters of the TINS. The research assistant/investigator will apply the electrodes and the PI will be blinded the stimulation setting as well. Unblinding is expected to occur after the 2 month follow up, at which point both subject and PI will be made aware of their group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute tSCI paraplegia within 4 weeks of injury (n=22)
- •18-75 years old
- •Neurologic levels T1-T10
- •English speaking
- •Admitted to TIRR with pain medications
- •TINS can elicit visible or palpable abdominal muscle contraction
排除标准
- •Subjects with pacemakers, defibrillators, insulin pumps, and similar devices
- •History of peripheral neuropathy
- •History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.)
- •History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative diseases such as Parkinson's disease, etc.)
- •Ventilator dependent respiration
- •Inability to speak
- •Non-English speakers
- •Pregnancy
- •History of chronic pain
- •Intolerant to electric stimulation
- •Intolerant to the trial sessions
结局指标
主要结局
Number of participants with morbidity as measured by infections
时间窗: 2-month follow-up
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking infections.
Number of participants with morbidity as measured by urgent transfers.
时间窗: 2-month follow up
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking urgent transfers
Number of participants with morbidity as measured by burns.
时间窗: 2-month follow-up
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking burns.
Number of participants with morbidity as measured by spasticity scores per usual care.
时间窗: 2-month follow-up
Observe the safety of using TINS during acute inpatient rehabilitation by prospectively tracking spasticity scores recorded per usual care
次要结局
- Number of participants with decreased pain medication dosage compared at discharge and 2-month follow-up.(2-month follow-up)
- Number of participants with improved spasiticy scores as measured by PENN SPASM FREQUENCY SCALE (PSFS)(2-month follow-up)
研究者
Argyrios Stampas, MD
Spinal Cord Injury Medicine Research Director
The University of Texas Health Science Center, Houston