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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Paris, 프랑스, 75013
- Centre d'investigation Clinique Pitié Salpêtrière
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Severity of symptoms after each phase
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Severity of symptoms after each phase
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Luc Mallet, MD, PhD, Assitance publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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