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临床试验/NCT07211919
NCT07211919已完成不适用

Functional MRI Guided Accelerated Intermittent Theta Burst Stimulation for Chronic Post-Concussive Syndrome: A Feasibility and Efficacy Retrospective Chart Review

Cognitive FX1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Post-Concussion Symptom Scale (PCSS) Score

研究概览

简要总结

This study looks at the effects of accelerated intermittent theta burst stimulation (aiTBS) on patients with chronic and acute post-concussion syndrome. Each participant was treated in an outpatient setting for about 3 hours per day, over 3 days. The participants' symptom survey scores and brain scan data were then compared before and after treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic or acute concussion symptoms

排除标准

  • MDD, GAD, bipolar depression, PTSD, schizophrenia, metal implants in skull, pacemaker, history of seizures, epilepsy

结局指标

主要结局

Post-Concussion Symptom Scale (PCSS) Score

时间窗: Scores taken prior to intervention, immediately post-intervention, and 1-4 weeks post-intervention

PCSS (post-concussion symptom scale) is a 21-question Likert scale questionnaire regarding physical, cognitive, sleep, and emotional symptoms of post-concussion syndrome. Minimum score on the scale is zero, maximum score is 126. Higher score indicates more severe symptoms.

Beck Anxiety Inventory (BAI) Score

时间窗: Immediately prior to treatment, after treatment, and 1-4 weeks post-treatment

Beck Anxiety Inventory is a 21-question Likert scale questionnaire used for measuring severity of anxiety symptoms. Minimum score is zero, maximum score is 63. Higher score indicates more severe symptoms.

Beck Depression Inventory (BDI) Score

时间窗: Pre-treatment, immediately post-treatment, and 1-4 weeks post-treatment.

Beck Depression Inventory is a 21-question multiple choice self-report inventory used for measuring severity of depression. Minimum score is zero, maximum score is 63. Higher scores indicate more severe symptoms.

Functional Neurocognitive Imaging (fNCI) Score

时间窗: 1-4 weeks pre-treatment, 1-4 weeks post-treatment

The fNCI assessment protocol combines the validity of conventional neuropsychological testing standards with the reliability and objectivity of informational data output provided by fMRI. It is a scan comparing BOLD signal and blood flow from participant's brain scan against a normative database of healthy, non-injured brains. Higher scores represent further deviation from healthy baseline, with a minimum score of zero and no theoretical maximum score. Scores below 1 are within healthy range.

次要结局

未报告次要终点

研究者

发起方
Cognitive FX
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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