Treatment of Persistent Postconcussion Syndrome With Repetitive Transcranial Magnetic Stimulation Using Functional Near-Infrared Spectroscopy as a Biomarker of Response: Protocol for a Randomized Controlled Clinical Trial.
Treatment of Persistent Postconcussion Syndrome With Repetitive Transcranial Magnetic Stimulation Using Functional Near-Infrared Spectroscopy as a Biomarker of Response: Protocol for a Randomized Controlled Clinical Trial.
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DOI：
10.2196/31308
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发表时间：
2022-03-22
影响因子：
1.7
通讯作者：
Debert CT
中科院分区：
文献类型：
--
作者：
du Plessis S;Oni IK;Lapointe AP;Campbell C;Dunn JF;Debert CT
大约三分之一的脑震荡会导致持续性脑震荡后综合症 (PPCS)。重复经颅磁刺激 (rTMS) 是一种无创脑刺激形式，已广泛用于治疗难治性重度抑郁症，并且具有用于治疗 PPCS 患者的强大潜力。功能性近红外光谱 (fNIRS) 已被用作评估 PPCS 患者的工具，并且可以深入了解 PPCS 患者 rTMS 治疗的病理生理学。本研究的主要目的是使用 Rivermead 脑震荡后症状问卷来确定与假治疗相比，rTMS 治疗是否可以改善 PPCS 患者的症状负担。第二个目标是使用 fNIRS 探索 PPCS 参与者在 rTMS 后发生的神经病理生理学变化。探索性目标包括确定 PPCS 参与者的 rTMS 治疗是否也会改善生活质量、焦虑、抑郁症状、认知、创伤后应激和头痛继发的功能。总共 44 名患有 PPCS（>3 个月至 5 岁）的成年人（18-65 岁）将参加一项双盲、假对照、隐藏分配、随机临床试验。参与者将接受为期 4 周的 rTMS 治疗方案或假 rTMS 方案（20 次治疗）。左背外侧前额叶皮层将通过蒙特利尔神经病学研究所坐标进行定位。左背外侧前额叶皮层的 rTMS 治疗强度为静息运动阈值的 120%，频率为 10 Hz，10 个序列，每个序列 60 个脉冲（总共 600 个脉冲），序列间间隔为 45 秒。在开始 rTMS 治疗之前，将收集参与者和损伤特征、问卷（症状负担、生活质量、抑郁、焦虑、认知和头痛）和 fNIRS 评估。 rTMS 治疗后以及 rTMS 治疗后 1 个月和 3 个月将立即重复问卷调查和 fNIRS。结果参数将通过2路（治疗×时间）混合方差分析进行分析。截至 2021 年 5 月 6 日，该研究已招募 5 名参与者，其中 3 名已完成 rTMS 方案。该试验的预计完成日期为 2022 年 5 月。该试验将扩展我们对 rTMS 如何用作 PPCS 治疗选择的了解，并将通过 fNIRS 分析探索 rTMS 的神经病理生理学反应。 ClinicalTrials.gov NCT04568369； https://clinicaltrials.gov/ct2/show/NCT04568369 DERR1-10.2196/31308
Approximately one-third of all concussions lead to persistent postconcussion syndrome (PPCS). Repetitive transcranial magnetic stimulation (rTMS) is a form of noninvasive brain stimulation that has been extensively used to treat refractory major depressive disorder and has a strong potential to be used as a treatment for patients with PPCS. Functional near-infrared spectroscopy (fNIRS) has already been used as a tool to assess patients with PPCS and may provide insight into the pathophysiology of rTMS treatment in patients with PPCS. The primary objective of this research is to determine whether rTMS treatment improves symptom burden in patients with PPCS compared to sham treatment using the Rivermead postconcussion symptom questionnaire. The secondary objective is to explore the neuropathophysiological changes that occur following rTMS in participants with PPCS using fNIRS. Exploratory objectives include determining whether rTMS treatment in participants with PPCS will also improve quality of life, anxiety, depressive symptoms, cognition, posttraumatic stress, and function secondary to headaches. A total of 44 adults (18-65 years old) with PPCS (>3 months to 5 years) will participate in a double-blind, sham-controlled, concealed allocation, randomized clinical trial. The participants will engage in either a 4-week rTMS treatment protocol or sham rTMS protocol (20 treatments). The left dorsolateral prefrontal cortex will be located through Montreal Neurologic Institute coordinates. The intensity of the rTMS treatment over the left dorsolateral prefrontal cortex will be 120% of resting motor threshold, with a frequency of 10 Hz, 10 trains of 60 pulses per train (total of 600 pulses), and intertrain interval of 45 seconds. Prior to starting the rTMS treatment, participant and injury characteristics, questionnaires (symptom burden, quality of life, depression, anxiety, cognition, and headache), and fNIRS assessment will be collected. Repeat questionnaires and fNIRS will occur immediately after rTMS treatment and at 1 month and 3 months post rTMS. Outcome parameters will be analyzed by a 2-way (treatment × time) mixed analysis of variance. As of May 6, 2021, 5 participants have been recruited for the study, and 3 have completed the rTMS protocol. The estimated completion date of the trial is May 2022. This trial will expand our knowledge of how rTMS can be used as a treatment option of PPCS and will explore the neuropathophysiological response of rTMS through fNIRS analysis. ClinicalTrials.gov NCT04568369; https://clinicaltrials.gov/ct2/show/NCT04568369 DERR1-10.2196/31308