Acoustic neuromodulation with or without micro-voltage tACS reduces post-concussive symptoms.

IF 1.5 4区医学 Q4 NEUROSCIENCES

Brain injury Pub Date : 2025-05-12 Epub Date: 2025-02-06 DOI:10.1080/02699052.2024.2445709

Catherine L Tegeler, Thaddeus J Haight, Wesley R Cole, Hossam A Shaltout, Y Sammy Choi, Tyler E Harris, Nora Rachels, Paula G Bellini, Michael J Roy, Charles H Tegeler

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引用次数: 0

Abstract

Objective: Persistent post-concussive symptoms (PPCS) are common and disruptive, particularly in military service members (SM), yet there are no approved therapies targeting underlying physiological processes. This study was designed to compare acoustic neuromodulation using Cereset Research™ Standard Operating Procedures (CR-SOP), with Cereset Research Cranial Electrical Stimulation (CR-CES), on PPCS.

Methods: SM, veterans, or dependents with PPCS (Neurobehavioral Symptom Inventory [NSI] Score ≥23) were randomized to receive 10 sessions of engineered tones linked to brainwaves (CR-SOP) or 5 sessions of CR-CES, which adds intermittent low voltage transcranial alternating current stimulation (tACS) to CR-SOP. Designed to assess non-inferiority between varied doses of CR-SOP and CR-CES, the primary outcome was a change in post-concussive symptoms on the NSI, with secondary outcomes of heart rate variability (HRV) and self-report measures of PTSD, sleep, headaches, and depression.

Results: Among study participants (n = 80, 21.3% female, mean age 40.2 [SD 13.2], 4.8 deployments, 3.2 TBIs), mean NSI declined from 45.6 to 29.5 after intervention (p < 0.0001), with gains sustained at 3 months (29.7). No significant between group differences for NSI (CR-SOP: baseline 43.9, post-intervention 26.0, 3-month 27.2, and CR-CES 46.4, 30.7, and 31.1, respectively), and no evidence of inferiority between the groups with respect to NSI. Similar improvements were seen on PCL-5, ISI, HIT-6, and PHQ-9, with no HRV differences between groups.

Conclusion: Both acoustic neuromodulation alone (CR-SOP) and a lower dose of CR-SOP, with tACS added (CR-CES), significantly improved PPCS out to 3 months.

Registration: ClinicalTrials.gov - NCT03649958.

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有或没有微电压tACS的听神经调节可减少脑震荡后症状。

目的：持续性脑震荡后症状（PPCS）是常见和破坏性的，特别是在军人（SM）中，但目前还没有批准的针对潜在生理过程的治疗方法。本研究旨在比较使用Cereset Research™标准操作程序（CR-SOP）和Cereset Research颅电刺激（CR-CES）对PPCS的听神经调节。方法：将SM、退伍军人或患有PPCS（神经行为症状量表[NSI]评分≥23）的家属随机分为两组，分别接受10次工程音调连接脑电波（CR-SOP）或5次CR-CES，后者在CR-SOP的基础上增加了间歇性低压经颅交流电刺激（tACS）。旨在评估不同剂量CR-SOP和CR-CES之间的非劣效性，主要结局是脑震荡后NSI症状的改变，次要结局是心率变异性（HRV）和创伤后应激障碍、睡眠、头痛和抑郁的自我报告测量。结果：在研究参与者中（n = 80, 21.3%女性，平均年龄40.2 [SD 13.2]， 4.8次部署，3.2次tbi），干预后平均NSI从45.6下降到29.5 (p结论：单独听神经调节（CR-SOP）和低剂量CR-SOP加tACS (CR-CES)，显著改善PPCS 3个月。注册：ClinicalTrials.gov - NCT03649958。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Brain injury 医学-康复医学

CiteScore

3.50

自引率

5.30%

发文量

148

审稿时长

12 months

期刊介绍： Brain Injury publishes critical information relating to research and clinical practice, adult and pediatric populations. The journal covers a full range of relevant topics relating to clinical, translational, and basic science research. Manuscripts address emergency and acute medical care, acute and post-acute rehabilitation, family and vocational issues, and long-term supports. Coverage includes assessment and interventions for functional, communication, neurological and psychological disorders.