The Efficacy of Neural Stimulation in Individuals With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The State Social Paranoia Scale (SSPS)
研究概览
简要总结
The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.
详细描述
Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques [e.g., transcranial direct current stimulation (tDCS)] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.
This project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age = 18-64
- •Diagnosed with schizophrenia or schizoaffective disorder
- •Having current (in the past week) or recent (in the past month) paranoia
排除标准
- •Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70
- •Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
- •Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
- •History of electroconvulsive therapy
- •Lack of proficiency in English
- •Substance use disorder not in remission in the past 6 months
- •Any implanted devices such as pace maker, neurostimulator
- •Pregnancy
研究组 & 干预措施
Active anodal tDCS first, then Sham tDCS
Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.
干预措施: tDCS (Device)
Sham tDCS first, then Active anodal tDCS
Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.
干预措施: tDCS (Device)
结局指标
主要结局
The State Social Paranoia Scale (SSPS)
时间窗: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation
Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.
Ecological Momentary Assessment (EMA)-Based Paranoia
时间窗: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can't trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.
Birchwood Social Functioning Scale (SFS)
时间窗: The assessment was completed 30 minutes after completion of the active/sham stimulation
Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).
Ecological Momentary Assessment (EMA)-Based Social Functioning
时间窗: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).
次要结局
- The Trustworthiness Task(The assessment was completed 30 minutes after completion of the active/sham stimulation)
- The Scrambled-sentences Task (SST)(The assessment was completed 30 minutes after completion of the active/sham stimulation)
- The Ambiguous Intentions Hostility Questionnaire (AIHQ)(The assessment was completed 30 minutes after completion of the active/sham stimulation)
- The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)(The assessment was completed 30 minutes after completion of the active/sham stimulation)
研究者
Amy Pinkham, PhD
Principal Investigator
The University of Texas at Dallas