CTRI/2025/03/083241尚未招募3 期
A study to compare efficacy of high versus low frequency rtMS on Dorsolateral prefrontal cortex in neuropathic pain management among patients with spinal cord injury : A randomized controlled trial
AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年4月2日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
Neuropathic pain is a challenging complication of Spinal Cord Injury and current treatment options including pharmacological and non pharmacological interventions often fails to provide appropriate pain relief and are associated with undesirable side effects. rTMS has emerged as a promising non-invasive neuromodulation technique, with evidence suggesting its efficacy in modulating cortical excitability and alleviating neuropathic pain. This study compares high vs Low frequency rTMS for neuropathic pain in SCI patients, determining optimal frequency and examining depression relief as a confounding factor and using H-reflex parameters to quantify pain modulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Admitted Spinal cord injury patients to PMR ward or OPD, both traumatic and non traumatic.
- •Duration of injury at least 6 months from spinal cord injury.
- •Patients diagnosed with neuropathic pain.
- •Duration of injury of neuropathic pain more than 3 months.
- •Patients who are capable of or willing to give informed consent.
排除标准
- •Patients with any Intracranial metallic hardware such as electrodes, aneurysm clips or coils, stents and programmable ventriculoperitoneal shunts.
- •Patients with Implanted electronic device: cochlear implants, vagus nerve stimulators, pacemakers or implantable cardioverter defibrillators and spinal cord stimulators.
- •History of Vascular, traumatic, tumoral, Infectious brain lesion.
- •Patients not willing to give informed consent.
- •Patients with cognitive dysfunction who cannot cooperate.
- •Patients not having preserved visible voluntary muscle twitch in any hand in thenar muscles Patients with unstable vital signs.
结局指标
主要结局
VAS score
时间窗: Pre and post intervention
次要结局
- H reflex Parameters (H wave amplitude & latency, M wave amplitude & latency, H/M ratio)(Pre and Post intervention)
- Quality of life using ISCoS QoL data set(Pre and Post intervention)
- SF-MPQ-2(Pre and post intervention)
- AIS(Pre and post intervention)
- DASS- 21(Pre and Post intervetnion)
- MAS(Pre and Post intervention)
研究者
Anuj Patel
AIIMS New Delhi
研究点 (1)
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