Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Effects of taVNS on symptom severity in patients with PPCS
研究概览
简要总结
Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.
详细描述
PPCS occur in 30-50% of individuals following a concussion and can persist for months, causing somatic complaints (e.g., headaches and dizziness), cognitive impairments (e.g., memory and concentration issues), emotional disturbances (e.g., anxiety and depression), and sleep disorders. Despite their long-term consequences, effective treatments for PPCS remain scarce. Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising non-invasive technique that stimulates the auricular branch of the vagus nerve to induce bottom-up effects on brain activity, potentially alleviating PPCS.
This randomized, controlled, double-blind clinical trial will evaluate the cumulative and direct neurophysiological and clinical effects of taVNS (tVNS Technologies GmbH, Germany) in 48 patients aged 18 to 65 years who experienced a diagnosed concussion between 4 weeks and 1 year prior to enrollment and suffer from PPCS. Participants will be randomized to either an active taVNS group or a sham stimulation group.
Patients will undergo a total of 15 taVNS sessions over two weeks, including two visits at the University Hospital of Liège (first and last session) and 13 self-administered sessions at home. Symptom severity, including headaches, depression, anxiety, sleep disturbances, and overall quality of life, will be measured using validated questionnaires, while cognitive function (i.e., attention, working memory, executive functions) will be assessed through neuropsychological tests. Additionally, electroencephalographic (EEG) and electrocardiogram (ECG) recordings will be used to measure changes in brain activity and heart rate, respectively, focusing on alterations in power spectral density and functional connectivity patterns that may correlate with clinical improvements.
Follow-up assessments will occur one-month post-intervention via a phone call to collect questionnaires assessing symptom severity and quality of life.
This protocol aims to provide robust evidence on the efficacy and mechanisms of taVNS for PPCS while advancing our understanding of the neurophysiological changes associated with this therapeutic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age between 18 and 65;
- •Between 4 weeks and 1-year post-diagnosis of a concussion;
- •Score equal or above 16 on the Rivermead Post-Concussion Questionnaire;
- •Intact skin at the electrode site.
排除标准
- •History of chronic neurological or psychological disorders (still untreated 6 months preceding inclusion);
- •Pregnancy or breastfeeding;
- •Presence of an active implant (e.g., pacemaker, cochlear implant);
- •History of myocardial infarction or cardiac arrhythmia;
- •Excessive alcohol consumption (> 14 drinks per week) and/or drug (> 1x/week) use within the past 6 months.
结局指标
主要结局
Effects of taVNS on symptom severity in patients with PPCS
时间窗: From enrollment to the end of the study at 6 weeks (including follow-up).
The investigators will evaluate the effects of taVNS on the severity of PPCS, as measured by the Rivermead Post-Concussion Questionnaire (RPQ). The RPQ consists of 16 items scored on a 5-point Likert scale (0 = not experienced at all, 4 = severe problem). Total scores range from 0 to 64, with higher scores indicating worse symptom severity. The RPQ will be administered at four time points: baseline, mid-treatment, post-intervention, and one-month follow-up.
Effects of taVNS on brain activity in patients with PPCS
时间窗: From enrollment to the end of the treatment at 2 weeks.
The investigators will assess the effects of taVNS on brain activity using electroencephalography (EEG). Specific metrics analyzed will include: * Power spectral density across frequency bands: delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-45 Hz). * Functional connectivity patterns across cortical regions based on EEG coherence or phase-locking value. These parameters will be extracted from EEG data collected before and after the first and final taVNS sessions.
次要结局
- Effects of taVNS on cognitive functions in patients with PPCS(From enrollment to the end of the treatment at 2 weeks.)
- Effects of taVNS on verbal memory in patients with PPCS(From enrollement to the end of the treatment at 2 weeks.)
- Effects of taVNS on heart rate variability in patients with PPCS(From enrollment to the end of the treatment at 2 weeks.)
- Effects of taVNS on headaches in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effect of taVNS on sleep quality in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effects of taVNS on daytime sleepiness in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effects of taVNS on sleep changes in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effects of taVNS on depressive symptoms in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effects of taVNS on anxiety symptoms in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
- Effects of taVNS on quality of life in patients with PPCS(From enrollment to the end of the study at 6 weeks (including follow-up).)
研究者
Aurore Thibaut
Principal Investigator
University of Liege