Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.
详细描述
Generalized Anxiety Disorder (GAD) and chronic primary insomnia are highly prevalent and frequently co-occurring psychiatric conditions associated with significant functional impairment and reduced quality of life. Both disorders are characterized by dysregulation of cortical and subcortical neural circuits involved in emotional regulation and sleep-wake control, including abnormal oscillatory activity in fronto-limbic networks. Although pharmacological and psychotherapeutic interventions are considered first-line treatments, a substantial proportion of patients remain symptomatic or experience adverse effects, highlighting the need for novel neuromodulatory strategies.
Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that delivers low-intensity sinusoidal electrical currents at specific frequencies to entrain endogenous neural oscillations. By modulating frequency-specific cortical rhythms, tACS may influence neural synchrony and connectivity patterns implicated in anxiety and sleep disturbances.
The present study is an open-label, single-arm pilot clinical trial designed to investigate the feasibility, safety, tolerability, and preliminary clinical effects of tACS in adults with GAD and chronic insomnia. Participants will undergo 20 stimulation sessions administered over four consecutive weeks (five sessions per week). Stimulation will be delivered using the Nexalin device at a frequency of 77.5 Hz and an intensity of 15 mA. Electrodes will be positioned over the frontal pole (Fpz) and bilateral mastoid regions according to the international 10-20 EEG system.
Clinical assessments will be conducted at baseline, at the end of the 4-week treatment phase, and at a 4-week post-treatment follow-up visit. The study will examine changes in anxiety severity, sleep quality, mood symptoms, global clinical status, and cognitive/functional performance to characterize the potential therapeutic effects of this intervention.
The trial will be conducted at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical School (IPq-HCFMUSP). Findings from this pilot study are intended to inform the design of future randomized, sham-controlled clinical trials and contribute to the expanding investigation of transcranial alternating current stimulation as a potential treatment modality in anxiety and sleep disorders.
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
盲法说明
None (Open Label)
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 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score >5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg/day diazepam equivalent).
排除标准
- •History of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).
研究组 & 干预措施
tACS Group
Participants will receive 20 sessions of transcranial alternating current stimulation (tACS) over four weeks (five sessions per week). The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device, with electrodes placed at Fpz and mastoid areas.
干预措施: Transcranial Alternating Current Stimulation (tACS) (Device)
结局指标
主要结局
Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Baseline, Week 4, Week 8
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale ranging from 0 to 56, with higher scores indicating greater anxiety severity. The outcome measure is the change in total HAM-A score from baseline to Week 4 and Week 8.
Change in Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
时间窗: Baseline, Week 4, Week 8
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire ranging from 0 to 21, with higher scores indicating worse sleep quality. The outcome measure is the change in total PSQI score from baseline to Week 4 and Week 8.
次要结局
- Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (HAM-D)(Baseline, Week 4, Week 8)
- Change in Global Clinical Status Measured by the Clinical Global Impression (CGI) Scale(Baseline, Week 4, Week 8)
- Change in Quality of Life Measured by the WHOQOL-BREF(Baseline, Week 4, Week 8)
- Incidence of Treatment-Emergent Adverse Events(Throughout the 8-week study period)
研究者
Andre R Brunoni
Professor
University of Sao Paulo