SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Amplitude on EEG in speech-listen task
研究概览
简要总结
Auditory verbal hallucinations (AVH) are prevalent among patients with psychiatric disorders. Not only being highly stressful and functionally impairing, AVH often persist despite treatment. Recent attempts to treat AVH with add-on repetitive transcranial magnetic stimulation (rTMS) when targeting the temporoparietal junction (TPJ), a language node in the brain, has gained limited success. The aim of this investigation is to reduce AVH with rTMS using continous theta-burst stimulation over a novel target, the supplementary motor area (SMA), in participants with frequent AVH, while also assessing potential neurophysiological mechanisms underlying the symptom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical sham coil, masked by an independent person.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the AVH group:
- •Reported AVH with a minimum frequency of at least daily occurrence, with onset more than one month ago
- •Stable psychopharmacological treatment past month
- •Inclusion criteria for the non-AVH control group
- •Reporting no occurrences of AVH for the past year
- •Stable psychopharmacological treatment past month
- •Inclusion criteria for the healthy control group
- •No life-time occurrence of AVH
- •No history of psychiatric disorders as assessed with a Mini-International Neuropsychiatric Interview (M.I.N.I.)
排除标准
- •Ferromagnetic or electromagnetic implants that may pose a risk during magnetic resonance imaging (MRI) and/or cTBS
- •A history of epilepsy
- •Pregnancy
- •Current substance use disorder or a history of alcohol use disorder as assessed with Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), urine samples with test for illicit drugs and Phosphatidylethanol (PEth)
- •Daily benzodiazepine use
- •Factors that make the participant unlikely to be able to complete the study
结局指标
主要结局
Amplitude on EEG in speech-listen task
时间窗: 5-30 minutes after intervention
Neurophysiological outcome of the blinded cross-over phase
Change on The Psychotic Symptom Rating Scales (PSYRATS)
时间窗: 1 day after completion of open treatment phase
Auditory Verbal Hallucination symptom interview, total score
次要结局
- Double step saccade-task(20-60 minutes after intervention)
- Finger tapping test(5-30 minutes after intervention)
- Brief Psychiatric Rating Scale (BPRS)(1 day after completion of open treatment phase)
- Resting state functional magnetic resonance imaging (rsfMRI)(1 day after completion of open treatment phase)
- Magnetic resonance spectroscopy (MRS) over the SMA quantifying glutamate and gamma-aminobutyric acid (GABA) and other metabolites(1 day after completion of open treatment phase)
- App recorded ratings of auditory verbal hallucinations (AVH)(From first day of open treatment phase, and through one week after completion of treatment)