Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)
Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.
This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.
調査の概要
詳細な説明
Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.
Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Paris、フランス、75013
- Centre d'investigation Clinique Pitié Salpêtrière
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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 :
- Age 18 - 60
- OCD according to DSM IV, at least 5 years since diagnosis
- Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
- Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
- Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
- Oral and written knowledge of French
- Social security coverage
- Written consent of the patient after clear description of the study
Exclusion criteria :
- cognitive alteration with PM38 score < IQ85
- Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
- suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
- Personality disorder (axis 2 of DSM IV assessed using the SCID II)
- Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
- Fertile woman without adequate contraception
- Pregnancy
- Forced psychiatric hospitalisation
- Any kind of legal protection
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：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Deep brain stimulation of subthalamic nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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実験的：Deep brain stimulation of caudate nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Caudate nucleus stimulation
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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実験的：Deep brain stimulation of nucleus accumbens
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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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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Severity of symptoms after each phase
時間枠：3 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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3 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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Severity of symptoms after each phase
時間枠：month 0
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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month 0
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Severity of symptoms after each phase
時間枠：6 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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6 months
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Severity of symptoms after each phase
時間枠：10 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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10 months
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Severity of symptoms after each phase
時間枠：14 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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14 months
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協力者と研究者
捜査官
- 主任研究者：Luc Mallet, MD, PhD、Assitance publique - Hôpitaux de Paris
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 (見積もり)
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。
強迫性障害の臨床試験
Deep brain stimulationの臨床試験
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Rousselot BVBAKGK Science Inc.まだ募集していません
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Rotman Research Institute at Baycrest募集
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St. Joseph's Healthcare HamiltonPeter Boris Centre for Addictions Research (PBCAR)完了