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临床试验/NCT04856657
NCT04856657已完成不适用

Targeting Individual Alpha Frequencies to Enhance Perceptual Timing

University of Minnesota1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Double Flash Fusion Illusion Task

研究概览

简要总结

This is a single-blind randomized within-subject crossover design study that will be conducted in 2 phases. In Phase 1, up to 50 participants, after signing informed consent and determining eligibility, will undergo a baseline EEG and cognitive assessment. In Phase 2 participants will undergo tACS at IAF+2Hz, IAF-2Hz, and IAF during a double-flash illusion task in a randomized order. The tACS will be applied with a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (25 cm²) applied to the back of the head. The investigator's hypothesis is that participant's will perform better on the visual task while tACS is set to 2 Hz above their IAPF, relative to tACS set to 2 Hz below their IAPF.

详细描述

The proposed pilot study will assess the feasibility of transcranial alternating current stimulation (tACS) to enhance aspects of attention in people with psychotic disorders.

If a participant agrees to participate in this research, they will be asked to visit the study site to complete the activities listed below. These study activities will take about 5.5 hours to complete. The activities can be divided into up to 3 separate sessions as needed, but all activities should be completed within approximately one week.

Phase 1:

  • A clinical interview including an abbreviated MINI, consisting of the mood, mania, suicide, and psychosis modules to either: confirm a diagnosis of a psychotic disorder in Psychosis Subject recruits; or confirm no diagnosis of a psychotic disorder in Control Subject recruits. If any suicidal ideation is expressed on the suicide module, study staff will administer the C-SSRS.
  • All participants will complete the Wechsler Test of Adult Reading (WTAR) to obtain an estimate of average IQ, the Brief Assessment of Cognition (BAC app; including Verbal Learning, Digit Sequencing, Token Motor, Semantic Fluency, Symbol Coding, and Tower of London), the Edinburgh Handedness Inventory, and a brief demographic questionnaire.
  • Participants with psychosis will complete the PANSS clinical interview to assess psychosis symptoms. Controls will not complete the PANSS.
  • Next, participants will undergo a baseline EEG that includes measures of resting EEG (once at the beginning and once more at the end of the session) and a Double-Flash Fusion Illusion Task.

Phase 2:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Meet diagnostic criteria for a psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder), as defined by the MINI (Mini-International Neuropsychiatric Interview)
  • •Are age 18-64 (inclusive)
  • •Fluent in written and spoken English
  • •Have an outpatient status of at least 1 month prior to participation
  • •Has been on a stable dose of psychiatric medication for at least one month prior to participation (titration to a lower dose of psychotropic medications under supervision of a psychiatrist can be allowed at the discretion of the investigators)

排除标准

  • •History of seizures or epilepsy
  • •Metallic cranial plates, screws, or implanted devices
  • •History of craniotomy
  • •History of stroke
  • •History of eczema on scalp
  • •Pre-existing sores or lesions at sites of tACS electrode placement
  • •Non-removable facial piercings
  • •Current or possibility of current pregnancy
  • •Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the MINI and/or C-SSRS (All participants will complete the suicide module of the MINI. If participants express any suicidal ideation on the MINI, staff will complete the C-SSRS [Columbia-Suicide Severity Rating Scale].)
  • •WTAR (Wechsler Test of Adult Reading) standardized score below 70
  • •Any reason our tCS (transcranial stimulation) or EEG caps cannot be placed on their head
  • •Control Participants:
  • •Inclusion Criteria:
  • •Are age 18-64 (inclusive)
  • •Fluent in written and spoken English
  • •Exclusion Criteria:
  • •Meet diagnostic criteria for a psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder), as defined by the MINI
  • •Self-reports having a first-degree relative with a psychotic disorder
  • •History of seizures or epilepsy
  • •Metallic cranial plates, screws, or implanted devices
  • •History of craniotomy
  • •History of stroke
  • •History of eczema on scalp
  • •Pre-existing sores or lesions at sites of tACS electrode placement
  • •Non-removable facial piercings
  • •Current or possibility of current pregnancy
  • •Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the MINI and/or C-SSRS (All participants will complete the suicide module of the MINI. If participants express any suicidal ideation on the MINI, staff will complete the C-SSRS.)
  • •WTAR standardized score below 70
  • •Any reason our tCS or EEG caps cannot be placed on their head

结局指标

主要结局

Double Flash Fusion Illusion Task

时间窗: 2 20-minute task runs (one during tACS at IAPF + 2 Hz and one during tACS at IAPF - 2 Hz)

Participants are instructed to fixate their gaze on a central fixation cross. When the cue appears, a low-luminance disc stimulus flashes on either side (left or right) of the fixation cross. The disc can flash one or two times. After the stimulus ends, participants are cued to make a response regarding the number of disc flashes (1 or 2). Participants will undergo 300 trials. Participants will be scored on response accuracy (i.e., number of correct responses out of 300 possible responses).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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