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Transcranial Direct Current Stimulation Influences on Cognitive Inhibition in Schizophrenia

2018年4月25日 更新者:Nira Mashal、Bar-Ilan University, Israel
A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant responses and to adopt relevant responses instead. The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche & Paulus, 2001). The aim of this study is to test whether bilateral tDCS over the dorsolateral prefrontal cortex (DLPFC) differentially modify performance on several cognitive tasks.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

A deficit in cognitive suppression is a trait of patients with schizophrenia. Cognitive suppression is the ability to control or suppress irrelevant information and to adopt relevant responses instead. This ability is a basic skill which is essential to maintain a normal well-adjusted life. We need to suppress distracting information in order to focus attention, to suppress irrelevant cues in order to retrieve particular memories, and to suppress habitual responses in order to make adaptive choices (Dillon & Pizzagalli, 2007). The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on information suppression in schizophrenic patients. This is a noninvasive technique of brain stimulation that induces prolonged functional changes in the cerebral cortex through the application of a weak direct current to the scalp (Nitsche & Paulus, 2001; Nitsche et al., 2003, 2004; Antal et al., 2004). The aim of this study is to test whether anodal and cathodal tDCS differentially modify performance on several cognitive tasks when applied to the left/right dorsolateral prefrontal cortex (DLPFC).

Sixty patients will be divided into four groups: 1) 15 schizophrenic subjects in a tDCS treatment group; 2) 15 schizophrenic subjects in a sham tDCS group; 3) 15 healthy subjects in a tDCS treatment group; 4) 15 healthy subjects in a sham tDCS group. All participants will complete baseline tests including an n-back test, the Hayling test and metaphoric comprehension test. The schizophrenic subjects only, will complete a bank of cognitive tests as a baseline (MATRICS Consensus Cognitive Battery (MCCB). The first meeting for the schizophrenic subjects only will be used to determine the best stimulation area (right/left DLPFC) and type (anodal/ cathodal). Schizophrenic subjects in both the treatment and the control groups will undergo six treatment sessions in total. The cognitive tests will be given to all participants once again at the end of the study. In order to evaluate improvement between the pre-test and the post-test, differences in reaction times and error rate will be calculated for each participant.

This study is important for few reasons. First, this study focus on the difficulty of suppressing irrelevant information, executive function ability essential to leading a normal life. Special populations, and specifically people with schizophrenia, have difficulty suppressing irrelevant information, and a correlation has been noted between this characteristic and weak executive functioning capabilities. In this study we evaluate the potential of minimizing these difficulties through use of tDCS. This particular tool was chosen for the study because it is easy to use, non-invasive, and painless. Research has shown that tDCS stimulation of the DLPFC can improve performance in cognitive tasks, a result that has not been mirrored through use of medications. Second, in recognition of the heterogeneity of schizophrenic patients (substantiated by the fact that the success of other treatments varies from patient to patient), our study will perform tests to identify the preferred stimulation region, DLPFC left/right. The results will help determine more specifically if there is a degree of heterogeneity in terms of the region responsible for suppressing irrelevant information . Related to this, we will be able to assess the impact of stimulation, including whether or not stimulation benefits all schizophrenic patients or, alternatively, if there are unknown variables involved which determine the relative success of this treatment amongst individuals. In addition, we will be able to explore differences or correlations between healthy subjects' verbal abilities in relation to the various tests conducted, and assess the impact of these tests on healthy subjects' cognitive inhibition and working memory. Finally, this study is critical because if the treatment method proves to be successful, we would be able to extend this study to other populations that have difficulties with executive functioning, and in addition, to examine the effect of electrical stimulation on other cognitive abilities.

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Ramat-Gan、イスラエル、52621
        • The Chaim Sheba Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~55年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • must be 18 years old or above.
  • Clinical diagnosis of schizophrenia or schizoaffective disorder
  • must be with a stable mental status as demonstrated by a stable Positive and -Negative Symptom Score (PANSS) score over a period of 2 weeks.
  • must have no medication changes in the 2 weeks prior to obtaining informed consent.
  • must be able to give informed consent for the trial.

Exclusion Criteria:

  • Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  • Pregnant or breast-feeding.
  • current DSM-V substance or alcohol abuse.
  • Concurrent delirium
  • mental retardation
  • drug-induced psychosis
  • history of clinically significant brain trauma documented by CT or MRI.
  • epilepsy or had seizures 6 months prior the beginning of the study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
偽コンパレータ:シャムtDCS
the sham tDCS group. Neuropsychological testing and symptom ratings will be conducted at baseline and 4 weeks after the end of treatment
実験的:bilateral Anodal-L/R Cathodal-R/L tDCS

bilateral Anodal-left and cathodal-right tDCS over DLPFC or bilateral Anodal-right and cathodal-left tDCS over DLPFC.

Intervention: Device: transcranial direct current stimulation

arm Participants will receive bilateral anodal-left cathodal-right tDCS or anodal-right cathodal-left tDCS over the DLPFC.

The following parameters will be used: stimulation intensity of 2 milliAmps for 20 minutes (6 consecutive sessions ).

他の名前:
  • Active Comparator: sham tDCS

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression score on cognitive tasks
時間枠:two years
Improve performance in cognitive tasks in particular, higher scores on the MATRICS Consensus Cognitive Battery in the post vs. before intervention tests.
two years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Nira Mashal, Ph.D.、Bar-Ilan University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年1月1日

一次修了 (実際)

2018年3月7日

研究の完了 (実際)

2018年3月7日

試験登録日

最初に提出

2013年10月12日

QC基準を満たした最初の提出物

2013年10月28日

最初の投稿 (見積もり)

2013年10月29日

学習記録の更新

投稿された最後の更新 (実際)

2018年4月27日

QC基準を満たした最後の更新が送信されました

2018年4月25日

最終確認日

2018年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BARILAN-13-0116-MV-CTIL

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。