Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)
In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.
In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, 벨기에, 3000
- UZ Leuven
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- Failure of documented trial of cognitive and behavioural therapy
- Duration of illness: min. 5 year
- Y-BOCS at least 30/40.
- Age: 20-65 year
Exclusion Criteria:
- DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- Present or past history of psychotic symptoms.
- Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
- Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
- The patient must be juridical free.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: VC/VS stimulation ON followed by OFF
triple blind, randomised, two periods of three months
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다른 이름들:
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실험적: VC/VS stimulation OFF followed by ON
triple blind, randomised, two periods of three months
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Yale Brown Obsessive Compulsive Scale (Y-BOCS)
기간: up to 12 months
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up to 12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Clinical Global Impression (CGI)
기간: up to 12 months
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up to 12 months
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Global assessment of functioning (GAF)
기간: up to 12 months
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up to 12 months
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Hamilton scale for anxiety
기간: up to 12 months
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up to 12 months
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Beck depression inventory
기간: up to 12 months
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up to 12 months
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Inventory of Depressive Symptoms (IDS)
기간: up to 12 months
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up to 12 months
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Patient Global Impression (PGI).
기간: up to 12 months
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up to 12 months
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Symptom Checklist (SCL-90)
기간: up to 12 months
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up to 12 months
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Quality of Life and Satisfaction Questionnaire (Q-Les-Q)
기간: up to 12 months
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up to 12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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. .