To Enhance Cognition in Late Life Depression Using Transcranial Direct Current Stimulation
Enhancing Cognition in Patients With Late-Life Depression: A Randomized Controlled Trial of Transcranial Direct Current Stimulation
調査の概要
詳細な説明
tDCS is a non-invasive brain stimulation method that utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. tDCS produces its effects through long lasting changes in neuroplasticity: in animal studies, tDCS results in long-term potentiation and brain-derived neurotrophic factor secretion; in human studies, tDCS results in potentiation of neurophysiologic markers of neuroplasticity. Consistent with these preclinical findings, tDCS to the temporoparietal cortex or left DLPFC improves memory in patients with mild to moderate Alzheimer disease(AD). tDCS has also been tested among patients with depression - including by our group - but mainly as a treatment for depressive symptoms. In one recent large study one session of bilateral anodal tDCS was shown to enhance working memory among midlife participants with major depression prior to receiving any treatment. However, it is still not known (1) whether tDCS improves cognition beyond the partial improvement that is associated with resolution of depressive symptoms; or (2) whether it has a more fundamental and long lasting effect on cognition.
This trial will assess the acute and long-term effects of a 2-week course of daily (5 days/week) bilateral anodal tDCS of the DLPFC on cognition, and in particular working memory among 36 patients with LLD. We will recruit and randomize participants who have already been treated for LLD prior to consenting to the study and who still meet criteria for remission while on antidepressant medications.
This trial will also be used as a platform to explore the effect of tDCS on neurophysiologic measures of plasticity during working memory performance. Working memory is supported by re-entrant circuits, some are local within the DLPFC and others are long-range connecting the DLPFC to more posterior cortices. These networks result in high and low frequency neuronal oscillations that can be captured by electroencephalography (EEG). Using novel neurophysiologic analyses, our group and others have demonstrated that the modulation of high-frequency (particularly gamma) oscillations by low-frequency (particularly theta) oscillations - "theta-gamma coupling" - is a neurophysiologic marker of working memory. Thus, we will explore the effect of tDCS on theta-gamma coupling.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M6J1H4
- Center for Addiction and Mental Health
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Women and men of any races or ethnicity
- Age 60 and above
- Major depressive disorder, single or recurrent per SCID DSM-IV criteria AND remission from that episode as defined by DSM IV-TR criteria for remission.
- Montgomery-Asberg Depression Rating Scale (MADRS) score less than 10.
- Ability to speak English fluently enough to complete all research assessments.
- Corrected visual ability to read newspaper headlines; hearing capacity to respond to a raised conversational voice
- Willingness and ability to provide consent
Exclusion Criteria:
- DSM IV TR criteria for any dementia
- DSM IV TR criteria for life-time bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders
- DSM IV TR criteria for any substance abuse or dependence within the past 6 months
- Presence of psychotic features or any other symptoms that would make the participant unable to participate in the study.
- Any medical contra-indications to tDCS.
- Electroconvulsive therapy in the last 6 months.
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Active TDCS
2-week course of daily (5 days/week) active bilateral anodal TDCS, duration 30 minute each session.
Current 2 mA.
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Active Stimulation
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偽コンパレータ：Sham TDCS
2-week course of daily (5 days/week) Sham bilateral tDCS.
Duration 30 minute each session.
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Sham Stimulation
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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 |
時間枠 |
|---|---|
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To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
時間枠：Two weeks following the TDCS course
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Two weeks following the TDCS course
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To compare performance on working memory task (N-Back) and neuropsychological battery between active and sham TDCS groups
時間枠：Three months following the TDCS course
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Three months following the TDCS course
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.
時間枠：Two weeks following the TDCS
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Two weeks following the TDCS
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To compare theta-gamma coupling as measured by electroencephalography between active and sham TDCS groups.
時間枠：3 months following the TDCS
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3 months following the TDCS
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協力者と研究者
捜査官
- 主任研究者：Tarek K Rajji, MD、Center for Addiction and Mental Health
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
Active TDCSの臨床試験
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Federal University of Paraíba募集
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Second Affiliated Hospital, School of Medicine,...Hangzhou Seventh People's Hospital, Affiliated Mental Health Center, Zhejiang University School...まだ募集していません
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Indiana UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Michigan と他の協力者完了
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University of ReadingAmino Up Chemicals Co., Ltd.完了
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University of BathRoyal United Hospitals Bath NHS Foundation Trust完了