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临床试验/NCT03756610
NCT03756610Unknown不适用

Transcranial Alternating Current Stimulation (tACS) for Cognitive Impairments in Patients With Schizophrenia: a Randomized Controlled Trial

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
changes in The MATRICS Consensus Cognitive Battery (MCCB)

研究概览

简要总结

This trial attempts to investigate whether 10 sessions of tACS improves cognitive function, especially which domains of cognitive function are most improved and to investigate whether 10 sessions of tACS affecting brain activation during a working memory task and changes patterns of brain connectivity networks.Subjects will be divided into 2 groups 2:1, active and sham tACS. 50 subjects will be in the active group, and 25 subjects in the sham group (specific numbers to be decided on later).

详细描述

Schizophrenia patients (SZ) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. Cognitive deficits may be more important in preventing functional, occupational, and social recovery in SZ than other symptom domains and are not effectively treated by current pharmacological approaches. Alternating current stimulation (tACS) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rTMS), easily available, and has a good safety profile in healthy controls (HC) and SZ. The ability to entrain γ oscillations with 40Hz tACS, might compensate more specifically for this deficit in γ oscillations in schizophrenia, and, may therefore, produce more robust behavioral improvements in working memory and other aspects of cognition.However, no studies have looked at the effects of multiple daily tACS stimulation at a 40HZ γ frequency on cognitive function and symptoms in schizophrenia. This provides a rationale for the current study, which proposes to investigate the effects of 10 sessions of 40HZ tACS on cognitive functions, symptoms in schizophrenia.

Active vs. sham treatment will be randomly assigned in a 2:1 fashion (A:S) in groups using computer generated lists. Subjects and tDCS testers or evaluators will be blind to treatment. Subjects will be evaluated with cognitive, symptom and functional measures at baseline, within 1 day ( or 2 days fro some measures) after 10 sessions, 2 weeks after 10 sessions, 1 month after 10 sessions, and 2 months after 10 sessions.After the 1 month evaluation, subjects in the initial active tACS group will be randomly assigned to receive either 5 booster sessions of either active or sham tACS ( 25 subjects each), following parameters used in the initial treatment. Subjects in the initial Sham group will receive 5 booster session Sham tACS. Participants will be scanned once prior to tACS sessions, and within 3 days after the 10th tACS session, using our Siemens 3T Tim Verio MRI scanner with a standard 32-channel phased-array head coil.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS, and meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA), or schizophreniform disorder (SZF), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.

排除标准

  • Patients with risk factors for an MRI scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).

研究组 & 干预措施

Active tACS & active boosting group

Active Comparator

The active tACS & active boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of active tACS.

干预措施: Active tACS (Device)

Active tACS & active boosting group

Active Comparator

The active tACS & active boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of active tACS.

干预措施: Active boosting (Device)

Active tACS & sham boosting group

Other

The active tACS & sham boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

干预措施: Active tACS (Device)

Active tACS & sham boosting group

Other

The active tACS & sham boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

干预措施: Sham boosting (Device)

Sham tACS & sham boosting group

Sham Comparator

The sham tACS & sham boosting group will be stimulated with 10 sessions of sham alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

干预措施: Sham boosting (Device)

Sham tACS & sham boosting group

Sham Comparator

The sham tACS & sham boosting group will be stimulated with 10 sessions of sham alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

干预措施: Sham tACS (Device)

结局指标

主要结局

changes in The MATRICS Consensus Cognitive Battery (MCCB)

时间窗: Change from Baseline MCCB at 2 weeks.

changes in Neuroimage changes in Magnetic Resonance Imaging (MRI)

时间窗: Change from Baseline at 2 weeks.

Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)

changes in Gamma oscillation intensity ( 40-80 Hz) over the left and right frontal lobe

时间窗: Change from Baseline at 2 weeks.

measured by electroencephalogram (EEG)

次要结局

  • Side-effects of tACS(At each stimulation session,up to 2 weeks.)
  • The Positive and Negative Syndrome Scale (PANSS)(At baseline,2-week, 4-week, and 8-week follow-up.)
  • The MATRICS Consensus Cognitive Battery (MCCB)(At 4-week and 8-week follow-up.)
  • N-back task(At baseline,1-week, 2-week, 4-week, and 8-week follow-up.)
  • The Paced Auditory Serial Addition Task (PASAT)(At baseline,2-week, 4-week, and 8-week follow-up.)
  • The USCD Performance- Based Skills Assessment Battery (UPSA)(At baseline,2-week, 4-week, and 8-week follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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