A Randomized Controlled Pilot Trial of Low-resolution Brain Electromagnetic Tomography (LORETA) Neurofeedback Training for Treatment-resistant Auditory Verbal Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Rates of adverse psychiatric events
研究概览
简要总结
This study's primary objective is to perform a randomized controlled pilot study to assess the feasibility of using EEG-based neurofeedback to reduce the severity of treatment-resistant auditory verbal hallucinations ('hearing voices') in patients diagnosed with schizophrenia. Patients will be randomized to receive either EEG-based neurofeedback or treatment-as-usual.
详细描述
Auditory verbal hallucinations (AVH) are experienced by up to 80% of patients diagnosed with schizophrenia, where they can cause significant occupational and social impairment. Current treatments are incompletely effective. Around 25-30% of AVH are refractory to antipsychotic drugs, and cognitive behavioural therapy only shows a small-medium effect size. Initially promising studies of neurostimulation have shown smaller effect sizes as better controlled trials have been conducted. There is hence the need for innovative new treatments. One potential option is neurofeedback training. The primary objective of study is to perform a randomized, controlled, rater-blinded pilot trial (n=40) of EEG neurofeedback for AVH in patients with treatment-resistant schizophrenia, to assess trial process, which will then inform a future definitive trial. The secondary objective is to calculate a 95% confidence interval that will allow interpretation of statistical difference between neurofeedback and treatment-as-usual groups to assess neurofeedback for reducing auditory verbal hallucinations. Participants will be randomly allocated to either a neurofeedback (plus treatment-as-usual) or treatment-as-usual alone condition. Neurofeedback will employ Z-score based LORETA (Low Resolution Brain Electromagnetic Tomography). After a baseline assessment, twenty sessions of personalized neurofeedback training will be delivered over a period of approximately four months. This is the first registered trial of EEG neurofeedback for hallucinations. The primary focus of the pilot trial is on feasibility. However, a 95% confidence interval will be determined for the difference on PSYRATS-AH and AHRS scores between neurofeedback and treatment-as-usual to help inform a future definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- •Are ≥ 18 years old
- •Have a clinical diagnosis of a schizophrenia-spectrum disorder
- •Have been experiencing auditory verbal hallucinations for at least one year
- •Score 2 or more on the frequency item of the auditory hallucinations subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH; Haddock et al., 1999) at time of initial assessment (representing voices occurring at least once a day)
- •Are deemed refractory to antipsychotic treatment (defined as still hearing voices despite 4-6 weeks of treatment with two different antipsychotics)
- •Have been on a stable dose of antipsychotic medication for the three months prior to study enrolment
- •Are right-handed, as determined by the Edinburgh Handedness Inventory (Oldfield, 1971)
- •Are able to provide written, informed consent.
排除标准
- •Having a diagnosed substance abuse disorder
- •Prior head injury with loss of consciousness for more than five minutes
- •At immediate risk of harm to self or others.
研究组 & 干预措施
LORETA
In the first session, Low Resolution Brain Electromagnetic Tomography (LORETA) will be used in combination with Z-scores to identify participants' resting state EEG differences relative to a database of norms of their demographic. EEG abnormalities which are consistent with the research literature on neural changes associated with AVH will then be targeted for normalization using neurofeedback training using LORETA in combination with Z-scores.
干预措施: LORETA (Other)
Treatment as usual
Maintenance use of an atypical antipsychotic (e.g., clozapine) with support, when needed, of a community nurse.
干预措施: Treatment as usual (Other)
LORETA
In the first session, Low Resolution Brain Electromagnetic Tomography (LORETA) will be used in combination with Z-scores to identify participants' resting state EEG differences relative to a database of norms of their demographic. EEG abnormalities which are consistent with the research literature on neural changes associated with AVH will then be targeted for normalization using neurofeedback training using LORETA in combination with Z-scores.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Rates of adverse psychiatric events
时间窗: 24 months
We will assess the proportion of patients entered into the trial who experienced adverse psychiatric events reported.
Drop-out rate: Controls
时间窗: 24 months
We will measure the proportion of patients who were entered into the trial, randomised to the control condition, and dropped out of the study.
Willingness of participants to be randomised.
时间窗: 24 months
We will measure the proportion of patients who were entered in the trial but refused randomisation.
Success of blinding of raters
时间窗: 24 months
We will measure the proportion of blind raters who were correctly able to guess the group allocation of participants, and assess if this was greater than chance.
Recruitment rate
时间窗: 24 months
We will measure how many patients were recruited into the trial per calendar month of active recruitment.
Willingness of participants to complete assessments
时间窗: 24 months
We will measure the proportion of participants who were entered into the trial and completed all baseline assessment measures.
Drop-out rate: LORETA condition
时间窗: 24 months
We will measure the proportion of patients who were entered into the trial, randomised to the neurofeedback condition, and dropped out of the study.
次要结局
- Delusions Subscale of the Psychotic Symptom Ratings (PSYRATS-D).(End of intervention (~4 months))
- Auditory Hallucinations Rating Scale (AHRS)(End of intervention (~4 months))
- Hospital Anxiety and Depression scale(End of intervention (~4 months))
- Auditory Hallucination Subscale of the Psychotic Symptom Ratings Scale (PSYRATS-AH)(End of intervention (~4 months))
- Quality of Life Enjoyment and Satisfaction Questionnaire(End of intervention (~4 months))
研究者
Simon McCarthy-Jones
Associate Professor in Clinical Psychology and Neuropsychology
University of Dublin, Trinity College