Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS
研究概览
简要总结
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
- •Age 18-65 years at the time of mTBI
- •High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35*
排除标准
- •Inability to tolerate imaging; contraindication of imaging due to implants or metal
- •Seizure disorder, active alcohol or substance use disorder
- •Inability to speak and read English
- •Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- •Subject is pregnant or breast feeding
- •Subject has participated in a clinical interventional trial in the last 3 months
研究组 & 干预措施
Theta burst stimulation
There will be a total of 25 theta burst sessions across 5 treatment visits (5 sessions per treatment visit), over a two-week period. Treatment will be applied to 2 brain regions of interest or parcellations: (1) Left 8AV; 2) A personalized region based on imaging and symptom profile.
干预措施: Intermittent theta burst stimulation (Device)
结局指标
主要结局
Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS
时间窗: baseline
Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.
Anomalous parcellations - developing the method of personalization of TMS targets for PPCS
时间窗: baseline
Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles
Distribution of complaints for PPCS
时间窗: baseline
Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen
Mapping of complaints to anomalous parcellations
时间窗: baseline
Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities
次要结局
- Feasibility - rate of completed treatment(4 weeks)
- Fidelity(4 weeks)
- Safety - adverse events(16 weeks)
- Acceptability(4 weeks)