ACTRN12621000498897招募中未知
ovel high-definition transcranial grey noise stimulation (HD-tGNS) for the treatment of Major Depressive Disorder: A proof of concept study
Dirk De Ridder0 个研究点目标入组 24 人开始时间: 2021年4月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years(—)
- 性别
- All
入选标准
- •Participants with a diagnosis of MDD will be eligible to participate. To be included in the study, participants must meet all of the following inclusion criteria:
- •Capable of understanding the study information and able to sign the informed consent form.
- •Age between 18 to 60 years on the day of the consent.
- •A score lower than three on the Maudsley Staging Method for treatment resistant depression.
排除标准
- •Participants who meet any of the following conditions will be excluded:
- •Other mental illness
- •History of neurological diseases
- •History of epilepsy or seizures
- •History of substance abuse,
- •Previous treatment with neuromodulation (e.g. Transcranial magnetic stimulation, electroconvulsive therapy, Neurofeedback, etc.)
- •Dyslipidaemia
- •Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease): A total score of 24 or below on Mini-Mental State Examination
- •History of uncontrolled/untreated hypertension
- •Presence of any pacemaker or defibrillator
- •Presence of any electronic implants or metal implant in the body (particularly head and neck)
- •Recent or current pregnancy
- •Note ~ Participants will be permitted to continue their medications for the duration of the trial, with the type and dosage of medication being recorded throughout the duration of the trial. However, participants with the intention of taking new medications in the next 2 months, will be excluded.
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