Deep Brain Stimulation: Towards a Novel Intervention Focused on the Recovery of Patients With Treatment-Resistant Schizophrenia: Randomized, Controlled, Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
研究概览
简要总结
The purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (TRS).
详细描述
The Project aims to improve the efficacy of the first worldwide study of Deep Brain Stimulation (DBS) carried out in our hospital -PI12 / 00042: Deep Brain Stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other DBS studies .
Moreover, and in line with the National Strategy of Mental Health of the National Health System, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the DBS treatment program, a psychological intervention module based on the recovery model. Therefore, the main objectives of the present project are:
i) to optimizethe efficacy and tolerability of DBS in TRS;
ii) investigate whether the REFOCUS intervention improves the recovery of patients who are being treated with DBS. To this end, a double-blind, randomized, crossover clinical trial of DBS will be performed for 6 patients with TRS. Patients will be randomized to receive tractography-based target guidance DBS in the anterior cingulate cortex (ACC) or the nucleus accumbens (Nac). The 21 patient previously intervened with DBS (Affective disorders and TRS) and the ones included in this project, will enter into a psychological intervention phase, based on the REFOCUS model
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18-50 years
- •Meet DSM-5 criteria for schizophrenia, with a duration of illness < than 15 years.
- •Meet updated TRS criteria.
- •Non-sustained response to electroconvulsive therapy.
排除标准
- •Contraindications to neurosurgery or DBS
- •Epilepsy or seizures clozapine-induced
- •Suicidal or self-harming behaviour in the last 6 months
- •Other psychiatric disorders (including personality disorders)
- •Significant cognitive impairment (Vocabulary test WAIS IV-TR, IQ <70, and SCIP<55)
- •Severe medical non-controlled diseases
- •Pregnancy or breastfeeding
- •Substance use disorders (except nicotine)
结局指标
主要结局
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
时间窗: Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)
Scale to assess changes in schizophrenia' symptoms
次要结局
- Questionnaire about the Process of Recovery (QPR)(Changes from baseline total score to 1-12 months total scores)
- Internalized stigma of mental illness scale (ISMI)(Changes from baseline total score to 12 months total scores)
- Beck Cognitive Insight Scale (BCIS)(Changes from baseline total score to 12 months total scores)
- Wisconsin Card Sorting Test (WCST)(Changes from baseline score to 12 months score.)
- EuroQol 5 dimensions-5 levels (EQ-5D-5L)(Changes from baseline score to 1-12 months scores)
- Client Satisfaction Questionnaire-8 (CSQ-8)(Changes from baseline score to 12 months score.)
- Clinical Global Impression - Schizophrenia (CGI-SCH)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Starkstein Apathy Scale (SAS)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Beck Depression Inventory (BDI)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Global Assessment of Functioning (GAF)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Rosenberg Self-Esteem Scale (RSES)(Changes from baseline total score to 12 months total scores)
- Herth Hope Index (HHI)(Changes from baseline total score to 12 months total scores)
- Personal Beliefs about Illness Questionnaire-Revised (PBIQ-R)(Changes from baseline total score to 12 months total scores)
- Trail Making Test (TMT A & B)(Changes from baseline score to 12 months score.)
- Rey Auditory Verbal Learning Test (RAVLT)(Changes from baseline score to 12 months score.)
- F-A-S Test(Changes from baseline score to 12 months score.)
- Personal and Social Performance scale (PSP)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Scale for the Assessment of Negative Symptoms (SANS)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Side Effect Rating Scale (UKU)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)
- Beck Anxiety Inventory (BAI)(Changes from baseline score to 1-3 weeks scores and to 1-12 months scores)