rTMS in Alleviating Pain and Co-morbid Symptoms in GWVI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Change from baseline to post treatment of depression
研究概览
简要总结
This study aims to look at the effectiveness of using repetitive transcranial magnetic stimulation (rTMS) in relieving pain and other co-morbid symptoms of Gulf War Illness.
详细描述
Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Likewise, depression carries a very high co-morbid rate (50%) in patients with chronic pain, and in GWV with GWI related chronic HA and body muscle and joint pain conditions (GWI-HAP). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating pain and other co-morbid symptoms of GWI.
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, Care Provider, Investigator)
盲法说明
This is a double-blinded study where only the statistician is aware of the randomization
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region
- •CDC Criteria for GWVI (GWI)
- •Kansas Criteria for GWVI (GWI)
- •International Headache Society Criteria for Migraine Headache without aura
- •Average Overall Daily Muscle Pain Intensity >3 on 0-10 a NPS
- •Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 a NPS
- •Headache Exacerbation/attack once a week with the average intensity >3 on a 0-10 NPS, lasting > 1 hour in the past three months
- •Hamilton Rating Scale of Depression (HRSD) greater than or equal to 14 based on the sum of scores for the first 17 items
排除标准
- •Pregnancy
- •History of pacemaker implant
- •Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
- •History of dementia, major psychiatric diseases, or life-threatening diseases
- •Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy
- •History of seizure
- •Pending litigation
- •Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
- •Lack of ability to understand the experimental protocol and to adequately communicate in English
- •History of Traumatic Brain injury
- •Chronic Tension or Cluster Headache
- •Ongoing Cognitive Rehabilitation or Treatment of PTSD
研究组 & 干预措施
Sham rTMS at the LMC
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
Active rTMS at the LDLPFC
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left dorsolateral prefrontal cortex (LDLPFC).
干预措施: Transcranial Magnetic Stimulation (Device)
Sham rTMS at the LDLPFC
Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LDLPFC.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
Active rTMS at the LMC
Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change from baseline to post treatment of depression
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Hamilton Rating Scale for Depression (HRSD) questionnaire will be used to assess depression, which consists of 21 questions and rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Only the first 17 items are used for the overall scoring. A score between 14 and 18 represents a moderate form of depression and a score greater than 19 represents severe depression.
Change from baseline to post treatment of body pain
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
A Brief Pain Inventory-Short Form (BPI-SF) questionnaire will also be used to assess the severity of pain and the impact of pain on daily functions. The BPI-SF consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine". Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes").
Change from baseline to post treatment of muscle pain
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The New Clinical Fibromyalgia Diagnostic Criteria - Part 1 will be used to assess muscle pain. Patients will be asked to rate the average (over the past 24 hours) intensity of muscle pain for up to 12 locations of the body.
Change from baseline to post treatment of quality of life
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Short Form Health Survey-36 (SF-36) is a self-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health.
Change from baseline to post treatment of fibromyalgia
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
A Revised Fibromyalgia Impact Questionnaire will be used to evaluate the function, overall impact and symptoms of Fibromyalgia. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always."
Change from baseline to post treatment of sleep difficulties
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Insomnia Severity Index measures the severity of an individual's sleep difficulties. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28.
Change from baseline to post treatment of GWI-related pain and headaches
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
This outcome will be measured through daily self-reporting logs that tracks headache, muscle, and joint pain. A numerical rating scale of 0, being no pain, to 10, being worst possible pain, will be used to report pain and headaches.
Change from baseline to post treatment of sensory and affective aspects of pain
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
Short Form McGill Pain Questionnaire (SF-MPQ): This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle and joint pain.
Change from baseline to post treatment of headaches
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Headache Impact Test (HIT-6) will be used to measure how headaches affect the individual's ability to function in different domains. This 6-question form assesses the severity of headache pain and is scored with a range of 36-78, with higher scores indicating a larger impact of headaches on functionality.
Change from baseline to post treatment of neurobehavioral symptoms
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
Change from baseline to post treatment of sleep quality
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Pittsburgh Sleep Quality Index (PSQI) questionnaire has nineteen individual items which are used to generate seven composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad."
Change from baseline to post treatment of fatigue
时间窗: Baseline, 1-week, 1-month, 2-month, and 3-month
The Flinders Fatigue Scale measures daytime fatigue associated with insomnia through a 7-item questionnaire. The questions range from 1-5, with 5 being "extremely" or "entirely."
次要结局
- Change from baseline to post treatment of PTSD symptoms(Baseline, 1-week, 1-month, 2-month, and 3-month)
- Explore changes in supraspinal resting state functional connectivity(Baseline and 1-week post treatment)
- Change in opioid-based pain medication usage(Baseline, 1-week, 1-month, 2-month, and 3-month)