STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 20
- 主要终点
- Number of responders
研究概览
简要总结
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers.
This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen.
Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia according to DSM 5.0 (Diagnostic and Statistical Manuel 5.0) criteria
- •Presence of symptoms despite the optimization of the antipsychotic dosage (based on prescriber's judgment) for at least 6 weeks, i.e. a dosage increase cannot be considered due to tolerability issues and/or is judged unlikely to bring sufficient clinical improvement. This will be operationalized by a minimum Negative PANSS score of 20 and at least one item scoring > 4; OR a minimum Positive PANSS score of 20 with at least one item scoring > 4 (e.g. delusion or hallucination), indicating persistent negative symptoms and/or persistent positive symptoms,
- •Patient under curatorship/guardianship or not
- •Age between 18 and 65 years old.
- •Covered by, or having the right to Social Security
- •Patient who understands the French language
- •Informed consent signed
排除标准
- •Other neuropsychiatric disorders (psychiatric history will be assessed using the MINI 6.0 (Mini International Neuropsychiatric Interview 6.0)) including bipolar disorders and mood depression disorders - (NB: Patients with substance related and addictive disorders will not be excluded from the study, but these data will be carefully recorded).
- •Contraindications for tDCS (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes),
- •Increase in total composite PANSS score of at least 20% between screening and enrollment visits
- •Women who are pregnant
- •Patients whose clinical condition requires in patient procedure under constraint
结局指标
主要结局
Number of responders
时间窗: Between baseline (day 0) and after 10-sessions of tDCS regimen (day 5)
The number of responders is based on the Positive and Negative Syndrome Scale (PANSS) score in the active and the sham group after 5 days of tDCS. According to Leucht et al (2009), response is defined as a decrease of at least 25% in the Positive and Negative Syndrome Scale (PANSS, Kay et al., 1987) score after the intervention.
次要结局
- Psycho-Sensory hAllucinations Scale (PSAS) score(Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session)
- Source monitoring test score(Baseline and day 5 (after 10-sessions of tDCS regimen))
- Auditory Hallucination Rating Scale (AHRS) score(Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session)
- Shortened Quality of Life questionnaire score(Baseline and 6 months after the last tDCS session)
- Brief Medication Questionnaire (BMQ) scores(Baseline and 3 months after the last tDCS session)
- Self-evaluation of Negative Symptoms (SNS) score(Baseline, 1 month and 3 months after the last tDCS session)
- Scale to assess Unawareness of Mental Disorder (SUMD) score(Baseline and 3 months after the last tDCS session)
- Medication Adherence rating Scale (MARS) score(Baseline and 3 months after the last tDCS session)
- Positive and Negative Syndrome Scale (PANSS) score(Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session)
- Anatomical magnetic resonance imaging (MRI)(Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session)
- Total serum Brain-Derived-Neurotrophic Factor (BDNF)(Baseline)
- Calgary Depression Scale for Schizophrenia (CDSS) score(Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session)
- Clinical Global Impression (CGI) score(Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session)
- Fargerström test score(Baseline, 1 month and 6 months after the last tDCS session)
- Functional magnetic resonance imaging (MRI)(Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session)
- Serum Brain-Derived-Neurotrophic Factor (BDNF) isoforms(Baseline)