Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Psychotic Symptom Rating Scale
研究概览
简要总结
The proposed study aims to use a form of neuromodulation, known as transcranial alternating current stimulation (tACS), to improve the effectiveness of the metacognitive training (MCT) program for treatment of delusions in schizophrenia. tACS is a non-invasive brain stimulation method utilizing weak electrical currents applied to the head to influence neural firing (Antal & Paulus, 2013). Brain regions implicated in delusional thinking will be targeted in the hopes of promoting thinking patterns that will allow participants to question delusional beliefs, reducing the severity of delusions and increasing the positive effects of MCT (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Electroencephalogram (EEG) and behavioural assessments will be used to measure treatment effects.
However, before tACS will be administered to individuals experiencing delusions associated with schizophrenia we will conduct various control-phase (pilot) studies to gain a better understanding on how tACS temporarily alters performance on cognitive processes by biasing dominant patterns of oscillations.
The objective of the pilot studies is to establish the effectiveness of the EGI GTEN system in modulating brain oscillations in the cortex of healthy participants by means of transcranial alternating current stimulation (tACS). In this control/pilot phase of our study, we aim to establish that we can induce changes in the power of a specific frequency band in targeted cortical regions with neuromodulation using the GTEN system, and we will assess whether doing so temporarily alters performance on simple cognitive and perceptual processes in healthy controls. This will be the first step towards translating our stimulation protocol to the patient population for our primary study of interest (tACS as an adjunct to metacognitive training for delusions in psychosis).
详细描述
Purpose:
The objective of this study is to enhance a form of nonpharmacological treatment of delusions in schizophrenia using neuromodulation, and confirm the effect using electroencephalogram (EEG) and behavioural measures (Whitman et al., in press; Whitman, Minz & Woodward, 2013). Specifically, transcranial alternating current stimulation (tACS) will be used to improve the outcome of participation in metacognitive training (MCT) for the treatment of psychosis.
MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions (Moritz et al., 2014).
tACS is a non-invasive brain stimulation technique in which a weak electrical current is applied to the head in order to change the likelihood of neural firing in a region of cortex under the stimulation electrodes (Antal & Paulus, 2013).
Hypothesis:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 19 to 60 years with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, or a mood disorder with psychotic features will be recruited for this study.
排除标准
- •An inability to read and write in English. Participants must be have used English on a daily basis for at least 5 years, and must be able to understand the consent form and give written consent.
- •Participants with an IQ score of 80 or lower.
- •A history of severe neurological disorder and those with severe manifestations of hostility, megalomania, formal thought disorder and suspiciousness will also be excluded from the analysis.
- •Subjects who are consistently disrupting the treatment group might be asked to leave, this will be at the discretion of the group instructor.
- •A history of neurological problems (e.g., stroke, aneurysm, Parkinson's, Multiple Sclerosis, encephalitis, meningitis, etc.)
- •History of seizure disorder or family history of seizure disorder.
- •History of migraines or other types of frequent severe headaches.
- •Metallic implants in head.
- •Severe head injury, frequent loss of consciousness and/or loss of consciousness greater than 30 minutes.
- •Recently suffered a serious concussion
- •Pregnancy
- •Very fatigued and/or recently experienced severe sleep disturbances
- •Medication known to increase risk of stroke and/or seizure.
- •Suffer from severe current substance dependence
- •Have a psychosis that is a direct consequence of substance abuse
- •For control-phase studies:
- •Subjects. We will recruit 440 participants total in the "Enhancement of Treatment of Delusions in Schizophrenia through Neuromodulation" study H16-01791; The current protocol describes the methods to be used in the Control Phase of our research, during which we will recruit 290 healthy controls between 19 and 60 years in order to establish proof-of-concept for using GTEN tACS in modulating brain oscillations and performance on simple cognitive tasks.
- •Exclusion criteria for healthy controls:
- •history of neurological problems (e.g., stroke, aneurysm, Parkinson's, Multiple Sclerosis, encephalitis, meningitis, etc.)
- •History of seizure disorder or family history of seizure disorder. While there is no direct evidence to suggest that tACS increases the risk of seizure in those with a history of seizure disorder in their family, research in this area is still relatively recent (< 15 years). Given the unlikely potential for an unknown elevated risk of seizure, we are including this as a conservative precautionary exclusion factor.
- •History of migraines or other types of frequent severe headaches. tACS can induce a headache in those prone to migraines and other forms of severe headaches.
- •Presence of metallic implants in head.
- •History of severe head injury, frequent loss of consciousness and/or loss of consciousness greater than 30 minutes.
- •Recent history of a serious concussion
- •Current pregnancy.
- •Symptoms of severe fatigued and/or recent experience of severe sleep disturbance.
- •Medication known to increase risk of stroke and/or seizure
结局指标
主要结局
Psychotic Symptom Rating Scale
时间窗: 8 weeks post-treatment
Delusion severity will be measured using the Delusions Scale of the Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, \& Faragher, 1999). The PSYRATS Delusion Scale measures specific aspects of delusions such as conviction and impact on thinking.
次要结局
- Scale for the Assessment of Negative Symptoms(8 weeks post-treatment)
- Signs and Symptoms of Psychotic Illness(8 weeks post-treatment)
- Electroencephalography Reasoning Bias (Evidence Matching Tasks)(8 weeks post-treatment)
- Bias Against Disconfirmatory Evidence Task(8 weeks post-treatment)
- Scale for the Assessment of Positive Symptoms(8 weeks post-treatment)
- Jumping to Conclusions Task(8 weeks post-treatment)
研究者
Todd Woodward
Professor
University of British Columbia