Non-invasive Neuromodulation of the Right Anterior Amygdala Using tACS: A Double-blind Randomized Sham Controlled Clinical Trial for the Treatment of Anxiety Related Disorders With an Open-Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Response rate informed by Beck Anxiety Inventory (BAI)
研究概览
简要总结
This is a clinical research trial exploring the efficacy of non-invasive neuromodulation (NM) intervention in the treatment of anxiety. The NM used in this study consists of 25 minutes of 5 hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions with a 3-4 week time period. The studied population includes patients with the following anxiety disorders: generalized anxiety disorder (GAD), social anxiety disorder (SAD), separation anxiety disorder of childhood, and post-traumatic stress disorder (PTSD). Participants will be randomly assigned to tACS or sham, cross-over, then followed by an optional open-label extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet SCID-5/MINI KID criteria for one of the above-mentioned anxiety disorders.
- •Subject, or legally acceptable representative (LAR), is able to read, understand, and provide written informed consent and assent, as applicable.
- •Subjects requiring an LAR will have an identified caregiver who meets the following criteria: Able to reliably report and communicate on the subject's level of functioning and either lives with the subject or sees the subject on average for ≥ 3 hours/day ≥ 4 days/week, or receives reports from a caregiver, such as an aide, who meets this criteria, and in the investigator's opinion - the extent of contact is sufficient to provide meaningful assessment of changes in subject behavior and function over time
- •Able to be compliant with all study procedures
- •Age range: 5 years of age or older
- •Stable medications for non-excluded concurrent medical conditions for eight weeks prior to randomization
- •If receiving psychotherapy, participants must have started psychotherapy at least 2 months prior to randomization
- •Health: Physically acceptable for the study with no expected medical conditions likely to occur during or immediately after the study, as confirmed by medical history
- •Clinical laboratory values of TSH and T4, within 90 days from randomization must be within normal limits or judged not clinically related by the physician sub-investigator or PI to the subject's cognitive impairment if abnormalities are present.
排除标准
- •Neurodegenerative disease
- •Intellectual Disability
- •Pregnancy or lactation
- •Convexity skull defects
- •Raised intracranial pressure
- •Intracranial electrodes
- •Vascular clips or shunts in the brain
- •Cardiac pacemakers or other implanted biomedical devices
- •An active medical disorder that could explain, in the opinion of the PI or by medical history, the anxiety disorder.
- •Had an abrupt and significant change in functioning within 3 months of randomization.
- •Meets criteria for any substance use addiction as defined by DSM-5/SCID-5 CV.
- •Active alcoholism as defined by 3 or more bottles of beer or glasses of wine or 2 hard liquor drinks per day/night 3 or > times per week at any time within the past 12 weeks of screening or any other addiction to non-prescription substances.
- •Schizophrenia spectrum disorders and bipolar spectrum disorders.
- •Active suicidal tendency (evaluated by Columbia-Suicide Severity Rating Scale [C-SSRS], traditional version). Note: If the BDI or CDS of the participants significantly increase, the CSSRS will be repeated.
- •Unstable medical condition (including expected medication change/titration).
- •Premenstrual dysphoric disorder.
- •Factious/malingering disorder and any patients applying for disability warranty.
- •Somatoform disorders subtypes: conversion and hypochondriasis.
结局指标
主要结局
Response rate informed by Beck Anxiety Inventory (BAI)
时间窗: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
BAI is a self-rated scale, with scores ranging from 0 to 63. We will calculate the treatment response rate as (pre-treatment BAI minus post-treatment BAI)/pre-treatment BAI
Hamilton Anxiety Rating Scale (HAMA)
时间窗: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
HAMA is a clinician-rated scale, with scores ranging from 0 to 56. We will calculate the treatment response rate as (pre-treatment HAMA minus post-treatment HAMA)/pre-treatment HAMA. We will compute the average of response rates from HAMA and BAI as the final outcome measure.
次要结局
- PTSD Checklist (PCL) for PTSD cohort(12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.)