Treatment of Neuropathic Pain Following Spinal Cord Injury - a Repetitive Transcranial Magnetic Stimulation Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version
研究概览
简要总结
This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI).
详细描述
Approximately 86,000 Canadians live with a spinal cord injury (SCI). Individuals with a SCI experience varying levels of deficits in motor and sensory function and sometimes paralysis. SCI can result in permanent impairments both physical and psychological, as the loss of body function greatly impacts quality of life. Neuropathic pain (NP) is a common complication following SCI. Damage or dysfunction to the nervous system after SCI commonly leads to secondary injury or disease in the somatosensory system, which may contribute to NP. This debilitating complication can impede many factors including physical function, rehabilitation, sleep, and return to work.
Treatment modalities for NP aim to reduce pain and improve function and quality of life. Pharmacological interventions are considered first-line therapy for NP management, though there remains limited evidence to support the efficacy of this treatment modality. Pharmacologic therapies may also include negative side effects. Additionally, clinical guidelines for NP management recommend including non-pharmacologic strategies. Therefore, an interdisciplinary strategy may be required to effectively mitigate NP after SCI. Evidence of neuromodulation techniques to improve various pain conditions is well established, and reductions in pain may be related to the modified brain activity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation intervention with a low risk of adverse effects. Preliminary studies investigating rTMS for NP after SCI have shown a therapeutic effect after treatment whereby quality of life and pain improved in this population.
RESEARCH QUESTION AND OBJECTIVES
This study aims to determine the clinical feasibility of a rTMS protocol to improve pain symptomology in adults with NP following SCI. Additionally, this study will contribute to the limited body of evidence for the efficacy of this treatment modality in this population.
The primary objective is to determine symptomatic changes in pain profile and treatment response using the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, a valid and reliably tested instrument, and the PROMIS Scale Neuropathic Pain Quality 5a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Physician-diagnosed spinal cord injury
- •Neuropathic pain for at least 3-months, as diagnosed by a physician
- •Pain not attributable to any other conditions
- •Aged 18-75 years
- •Can complete wheelchair transfers independently
排除标准
- •Prior history of transcranial magnetic stimulation (TMS) therapy
- •Any TMS-related contraindications, for example: pacemaker, metallic implant, other medical conditions such as structural brain disease, previous seizure, psychiatric disorders (excluding depression and anxiety), suicide attempt in the past 6 months, liver or kidney disease, malignancy, uncontrolled hypertension or diabetes, and current pregnancy or the desire to become pregnant in the next 6 months.
研究组 & 干预措施
Repetitive Transcranial Magnetic Stimulation (rTMS)
Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version
时间窗: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Pain profile, including location, intensity, and interference over the past 7 days will be assessed using the ISCIPBDS self-report tool.
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a
时间窗: To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.
Neuropathic pain will be assessed using the PROMIS Scale Neuropathic Pain Quality 5a questionnaire. This tool assesses 5 descriptors of neuropathic pain quality. Participants are asked to rate their pain quality from 1(not at all) to 5 (very much) using a recall period of the past 7 days.
次要结局
- Quality of Life Index Spinal Cord Injury version (QLI-SCI)(To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.)
- Pain Catastrophizing Scale (PCS)(To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.)
- World Health Organization Disability Assessment Schedule (WHODAS) 2.0(To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.)
- Generalized Anxiety Disorder scale-7 (GAD-7)(To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.)
- Patient Health Questionnaire-9 (PHQ-9)(To be assessed at baseline, after rTMS treatment (1-month), and at 1-month and 3-months after rTMS treatment.)