Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder
Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed.
Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms.
Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment
調査の概要
詳細な説明
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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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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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:
- Diagnosis of major depressive disorder
- Eligible to receive and recommended for rTMS for depression
- Willingness to complete computerized cognitive training and undergo brain stimulation procedures
- Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.
Exclusion Criteria:
- History of serious neurological illness or brain injury (e.g., stroke)
- Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
- Diagnosed intellectual disability
- Inability to manipulate a tablet device while seated in the rTMS chair
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：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Computerized Cognitive Training (CCT)
The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).
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After having four rTMS sessions without CCT, the patients will perform CCT (starting day 5) during the rTMS session, which typically last from 20-40 minutes.
A course of rTMS therapy includes from 25-36 treatments, given daily, until the last 5-6 treatments, given as a 'taper' over 2 weeks.
CCT will be paired with rTMS up until the taper begins.
In addition, they will have assessments prior to and after the therapy.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility assessed by percentage of CCT sessions completed during rTMS
時間枠：approximately 30 days (usually 20-30 sessions)
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Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
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approximately 30 days (usually 20-30 sessions)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time on task during treatment
時間枠：For each day: 45 min; for entire treatment: approx 30 days
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Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
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For each day: 45 min; for entire treatment: approx 30 days
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Acceptability of CCT
時間枠：through study completion date, up to 2 years
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Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
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through study completion date, up to 2 years
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Cognitive Control Performance change over course of treatment
時間枠：Approximately 30 days (usually 20-30 sessions)
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Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.
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Approximately 30 days (usually 20-30 sessions)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- HUM00161598
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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