Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Rivermead Post Concussion Symptoms Questionnaire
研究概览
简要总结
TMS has been safely and reliably delivered at the Harquail Centre for over 5 years, with a primary focus on conventional rTMS protocols for treatment-resistant depression. Recently, the investgator team has gained the capability to deliver sham-controlled intermittent theta-burst stimulation (iTBS) rTMS. Unlike conventional high frequency rTMS, which was used in the previous sham-controlled rTMS PCS pilot study, iTBS is a patterned form of stimulation that recapitulates endogenous activity patterns of neural circuits pairing gamma frequency (50Hz) burst pulses coupled in a theta frequency rhythm (5Hz).12 iTBS delivers 600 pulses in just over 3 minutes with similar or greater effects on neural plasticity compared to conventional rTMS (taking over 30-45 minutes) and similar tolerability and efficacy in trials of depression. Furthermore, novel accelerated iTBS protocols stimulating the left dorsolateral prefrontal cortex (dlPFC) over 8-10 treatments, 50 minutes apart over a 5 day interval has recently demonstrated robust efficacy in depression and received recent FDA approval. Thus, accelerated iTBS can be delivered in a single week of treatment compared to 6 weeks with conventional rTMS methods. Finally, the investigators recently acquired the technology to integrate MRI neuroimage-guided stimulation, which would allow to target specific brain regions/networks implicated in PCS at high spatial resolution. No studies to date have investigated image-guided accelerated iTBS rTMS for the treatment of PCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status.
- •At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation.
- •Onset of symptoms within 4 weeks following the head trauma.
- •Age 18-60, inclusive.
- •Persistence of PCS symptoms for at least 3 months but less than 12 months
- •Able to provide informed consent and comply with the study protocol
- •Patients will not be excluded solely on the basis of communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties.
排除标准
- •Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion)
- •History of prior rTMS therapy,
- •Contraindications to MRI (e.g., pacemaker, metallic implants etc.).
- •Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work.
- •Active personal injury litigation
- •History of seizure disorder, not including febrile seizures in childhood
- •Substance dependence within the last 6 months
- •Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy)
- •Currently taking an antiepileptic medication
- •Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)
- •A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment
结局指标
主要结局
Rivermead Post Concussion Symptoms Questionnaire
时间窗: 1 month post-treatment
RPQ, a validated measure of subjective global PCS symptoms.
次要结局
- Montgomery-Åsberg Depression Rating Scale(Baseline, post treatment day 5, and post treatment 1 month)
- Repeatable Battery for the Assessment of Neuropsychological Status(Baseline and post treatment 1 month)
- The Behavior Rating Inventory of Executive Function(Baseline, post treatment day 5, and post treatment 1 month)
- Headache Impact Test(Baseline and post treatment 1 month)
研究者
Dr. Sean Michael Nestor
clinician-investigator and interventional psychiatrist
Sunnybrook Health Sciences Centre