Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- Iris Sommer
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire
研究概览
简要总结
The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.
详细描述
Rationale: Auditory hallucinations (AH) are a symptom of several psychiatric disorders, such as schizophrenia. In the majority of patients, these AH respond well to antipsychotic medication. Yet, a significant minority continues to experience frequent AH despite optimal pharmacotherapy and AH severely decrease quality of life in these patients. The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. Transcranial direct current stimulation (tDCS), in contrast, is a safe, non-invasive technique that is able to directly influence cortical excitability through the application of very low electric currents. This technique has only a few transient side-effects and is cheap and portable. To date, only one randomized controlled trial has been published, suggesting high efficacy of tDCS for the treatment of medication-resistant AH in a relatively small sample. We aim to replicate and extend these findings by investigating the efficacy of this technique in a larger sample.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frequent auditory hallucinations (at least 5 times a week).
- •Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks
- •Mentally competent for informed consent.
- •Provided informed consent.
排除标准
- •Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
- •History of seizures, or a history of seizures in first-degree relatives.
- •History of eye trauma with a metal object or professional metal workers
- •History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
- •Skin disease on the scalp on the position of the tDCS electrodes
- •Coercive treatment based on a judicial ruling
- •Pregnancy in female patients
结局指标
主要结局
Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire
时间窗: 4 years
The primary outcome is the change in the severity of the hallucinations before and after the treatment, as experienced by the participant, measured with the Auditory Hallucination Rating Scale (AHRS)
次要结局
- Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire(4 years)
- Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)(4 years)
- Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)(4 years)
- Prior expectations regarding the efficacy of the treatment of the participants(4 years)
- Strength of the motor threshold as assessed using TMS(4 years)
- The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire(4 years)
- Interference score on the Stroop task(4 years)
- Score on the Trailmaking test A and B(4 years)