Combined Nonpharmacological Therapies for MTBI-Related Headaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Debilitating Headache Interference
研究概览
简要总结
This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
详细描述
This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups:
Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control
Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases:
- PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan);
- INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and
- POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19).
Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participant, study coordinators and the investigators will be blinded to the rTMS treatment. The participant will be blinded to the therapy group (headache management or headache education).
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
- •Mild Traumatic Brain Injury (mTBI)
- •Chronic headaches > 3 months after injury
- •No prior TMS treatment
- •Persistent Headaches with an intensity > 30 / 100
- •No history of daily headache prior to mTBI
排除标准
- •Pacemaker or any metal in body that would prevent MRI
- •History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
- •Presence of any other chronic neuropathic pain states
- •History of seizure
- •Pending litigation
- •Can't understand English
- •History of chronic headache like migraine prior to mTBI
- •Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
结局指标
主要结局
Debilitating Headache Interference
时间窗: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference.
Intensity of Debilitating Headaches
时间窗: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Persistent Headache Frequency
时间窗: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the frequency per week of persistent headaches
Debilitating Headache Frequency
时间窗: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the frequency per week of debilitating headaches
Intensity of Persistent Headaches
时间窗: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
次要结局
- Hamilton Rating Scale for Depression(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)
- Neurobehavioral Symptom Inventory(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)
- Rivermead Post-Concussion Symptoms Questionnaire(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)
- Headache Impact Test(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)
- Short-Form NEURO-QoL(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)
- Short Form Health Survey-36(Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit)