Improving Functions in MTBI Patients With Headache by rTMS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
研究概览
简要总结
Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).
详细描述
This study will only be conducted at the Veterans Affair hospital in San Diego.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age between 18 to 50
- •History of MTBI based on the clinical diagnostic criteria
- •History of headache more than 3 months
- •No prior experience of TMS treatment
- •Pre-treatment headache intensity M-VAS 30(0-100 scale) and average daily headache NPS 3(0-10 scale)
- •At least one headache exacerbation per day
- •A normal brain MRI in the past 3 months
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
- •History of seizure
- •Pending litigation
- •Lack of ability to understand the experimental protocol and to adequately communicate in English
- •History of chronic headache prior to the incidence of MTBI
研究组 & 干预措施
Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
干预措施: Transcranial Magnetic Stimulation (Device)
Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
时间窗: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.
Percent Change in Persistent Headache Prevalence
时间窗: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.
Percent Change in Persistent Headache Intensity
时间窗: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.
次要结局
- Percent Change in Depression Score From Baseline to 1-Week Post-treatment(Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.)