Decoded fMRI Neurofeedback for Auditory Verbal Hallucinations in Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Target Engagement
研究概览
简要总结
The purpose of this study is to learn whether a research neurofeedback training approach done during MRI scans may help reduce hallucinations such as the experience of hearing voices persistent despite treatment.
详细描述
The overall objective of the current study is to assess the target engagement and efficacy of active decoded neurofeedback (DecNef) as measured by how closely a participant's brain activity aligns with the desired non-AVH-related activation pattern and improvements in AVH measured via the Auditory Hallucination Rating Scale (AHRS). Dose-response curves of target engagement over sessions will be generated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 to 55, inclusive at screen
- •Capable of understanding the study procedures and willing and able to provide informed consent
- •Diagnosed with schizophrenia or schizoaffective disorder
- •Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.
- •Mean Auditory Hallucination Rating Scale (AHRS) score >2 (moderate) and AHRS Frequency ≥ 4 (hourly AVH: Frequent at least 3 to 6 per hour).
- •Meeting the decoder performance criterion, operationalized as ≥ 55% decoding accuracy. Baseline MRI may be repeated once for subthreshold decoder-accuracy at the discretion of the PIs.
- •Normal hearing, operationalized as normal conversational hearing.
- •Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for persons of childbearing potential only, unless post-menopausal or surgically sterile).
排除标准
- •Diagnosis of moderate or severe substance use disorder (excluding nicotine) within the previous 90 days
- •Positive toxicology screen for any substances of abuse
- •Participation in study of investigational medication/device within the past 4 weeks
- •Pregnant persons. Persons of child-bearing potential must have a negative urine β-hCG pregnancy test at Visit 1 and Visit 1a (if applicable)
- •Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise participant safety during study, including history of seizure, epilepsy in self or first degree relatives, stroke, brain surgery, head injury with loss of consciousness > 1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesions.
- •Contraindication to MRI scanning, including metal implants or clinically meaningful claustrophobia
- •Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 3 months prior to screening or participants who represent a significant risk of suicide or violence in the opinion of the investigator.
- •History of significant violent behavior in the past 3 months, posing a risk of homicide or having symptoms that would be exacerbated by study participation or travel to the site in the opinion of the investigator.
研究组 & 干预措施
Control
The active comparator is similar to the experimental condition but does not target schizophrenia symptoms.
干预措施: Decoded Neurofeedback (Device)
Active Decoded Neurofeedback
Decoded Neurofeedback is a real-time fMRI technique designed to modulate within-region activation patterns via pattern-based neurofeedback, which is thought to induce selective plasticity. In this study, we are targeting schizophrenia symptoms.
干预措施: Decoded Neurofeedback (Device)
结局指标
主要结局
Target Engagement
时间窗: During MRI sessions (from randomization through final MRI scan).
Target engagement will be evaluated by assessing how closely a participant's brain activity aligns with the desired activation pattern as determined by the fMRI decoder.
Auditory Hallucination Rating Scale
时间窗: During assessment administration (from randomization through final MRI scan)
The Auditory Hallucination Rating Scale (AHRS) will be the primary tool to evaluate auditory verbal hallucinations.
次要结局
未报告次要终点
研究者
Joshua Kantrowitz
Professor of Clinical Psychiatry
New York State Psychiatric Institute