Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial. (TMS VR)
Depression is a mood disorder affecting an individual in its entirety, altering its emotional and intellectual functioning . The major form of depression is the most common psychiatric disorder in Western countries. It is considered to be the most expensive psychiatric neurological disease in Europe and is currently treated by different methods.
However, almost a third of depressed patients shows no clinical improvement. Advances in neuroscience and understanding of neuromodulation have enabled the emergence of new treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of modulating the neuronal activity of a targeted brain region through a magnetic field applied by a coil. Even though this form of treatment has proven to be effective, it appears that more than half of depressed patients exhibited little to no response to it.
As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent signals, it was hypothesized that optimizing the effects of TMS with virtual reality is possible through the activation of these brain regions with sensory stimuli holding emotional valence (images, sounds) while using TMS concomitantly. Based on this new research premise, the investigators propose, in the context of an open and controlled clinical trial, to use a new media entitled virtual reality for displaying interactive virtual environments with positive emotional valence ( field of flowers, green valley) to a group of depressed patients undergoing TMS at the same time.
The study will include 66 depressed patients randomly assigned into two groups : TMS and Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two groups will be measured by questionnaires and brain functional imagery. This innovative and therapeutic approach will allow us to better understand the appropriate processes for modulating the neuronal activity in specific brain areas for treatment purposes.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Marseille、フランス、13354
- 募集
- Assistance Publique Hopitaux de Marseille
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コンタクト：
- Raphaëlle RICHIERI, PH
- 電話番号：+33 491435551
- メール：raphaellemarie.richieri@ap-hm.fr
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主任研究者：
- Raphaëlle RICHIERI, PH
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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:
- Criteria of resistant depression
- Age from 18 to 65 years old included.
- Primary diagnosis of major depression in subjects according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
- Informed consent and signed to participate in the study
Exclusion Criteria:
- Pregnant woman, parturient and nursing mothers.
- Absence of DSM-5 criteria for depression in subjects.
- Refusal to participate in the study.
- Modification of drug treatment in the month preceding inclusion.
- History of neurological pathology, head trauma or mental retardation.
- Presence of an addictive comorbidity.
- Presence of a major organic pathological.
- Presence of a contra-indication to virtual reality
- Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
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：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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プラセボコンパレーター：TMS
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
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アクティブコンパレータ：TMS with virtual reali
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20 sessions navigated with Conventional Transcranial Magnetic Stimulation
20 sessions navigated with virtual reality
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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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Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
時間枠：36 months
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a heteroevaluation scale of depressive semiology in 10 items.
A decrease of at least 50% in initial score at the Montgomery-asberg Depression Rating Scale.
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36 months
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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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Evaluation of The State Trait Anxiety Inventory Self-Questionnaire
時間枠：36 months
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40 items with, for each, 4 modalities of response, corresponding to degrees of intensity or frequency of the habitual or general emotional state of the patient.
The calculated score varies between 20 and 80, a high score indicating the presence of anxiety.
Anxiety will be assessed before the program begins and at the end of the program.
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36 months
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協力者と研究者
捜査官
- 主任研究者：Raphaëlle RICHIERI, PH、Assistance Publique Hopitaux de Marseille
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
Transcranial Magnetic Stimulation (TMS - ) MagPro®の臨床試験
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus Medical完了
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Assistance Publique Hopitaux De Marseille完了