Deep Electrical Neuromodulation in Obsessive-compulsive Disorder (NEP-TOC)
Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).
Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.
For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).
The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.
調査の概要
詳細な説明
The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.
The following data will be collected:
- Age, sex
- Medical, surgical and psychiatric history
- History of pharmacological treatments
- Elements from clinical examination
- any reported adverse effect
- scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
- results of biological, morphological, neuropsychological tests
- Stimulation parameters applied since implantation.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Montpellier、フランス、34295
- Uhmontpellier
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
- all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist
- treated by DBS at the CHU of Montpellier
Exclusion criteria:
- already enrolled in a study protocol at time of implantation
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
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 |
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
時間枠：Baseline
|
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS |
Baseline
|
|
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
時間枠：12 months
|
10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
時間枠：Baseline
|
a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults.
The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.
|
Baseline
|
|
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
時間枠：12 months
|
a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults.
The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.
|
12 months
|
協力者と研究者
捜査官
- 主任研究者：Fabienne CYPRIEN、University Hospital, Montpellier
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
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。