Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Bush-Francis Catatonia Rating Scale (BFCRS)
研究概览
简要总结
Nearly 10% of people hospitalized in psychiatry have a catatonic syndrome. The treatment of this syndrome is based on lorazepam and electro-convulsive therapy (ECT) in drug-resistant forms. ECT is the reference therapy, very effective in catatonia, but remain difficult to access due to the technical platform required for their realization, leading to delays in the implementation of the treatment responsible for an increase in the morbidity and mortality of catatonia. In this context, a new therapeutic tool available in the treatment of drug-resistant catatonia would improve the prognosis of catatonia. Transcranial direct current stimulation (tDCS) is an alternative, non-invasive brain stimulation technique that does not require anesthesia, and inexpensive and has been shown to be effective in depression and schizophrenia. A series of clinical cases suggests its potential efficacy in catatonia. Our objective is to evaluate the efficacy of tDCS in catatonia in a clinical trial.
详细描述
Catatonia is a pathology combining affective, motor, behavioural and neuro-vegetative symptoms. Nearly 10% of people hospitalized in psychiatry have a catatonic syndrome. However, it is a severe disorder with a potentially lethal course.
For the treatment of catatonia, lorazepam is effective in most cases, with the percentage of responding patients varying between 70 and 80 per cent, according to the literature. Catatonic episodes resistant to lorazepam are usually associated with chronic catatonia as part of a neurodevelopmental disorder. Genetic abnormalities are often found in these forms of catatonia.
Electroconvulsive therapy (ECT) should be considered for any catatonic episode that is resistant to lorazepam. It is also indicated when a rapid effect must be obtained in life-threatening situations (e.g. malignant catatonia) or when the underlying pathology requires this treatment. Its efficacy is considered excellent, with response rates ranging from 59% to 100%, including when patients have not responded to lorazepam.
There are several limitations to ECT treatment for catatonia:
- There are many centres, particularly in France, where ECT is inaccessible. Delays in access to ECT are particularly acute in rural areas.
- ECT requires a pre-therapeutic assessment, delaying treatment by several days. However, catatonic syndrome is an emergency requiring immediate treatment. Delaying treatment exposes the patient to the risk of aggravation, i.e. malignant catatonia, with a life-threatening outcome.
- ECT treatment is sometimes contraindicated because of contraindications to anaesthesia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women over 18 years old
- •Under the care of the GHU PARIS Psychiatry and Neurosciences or EPS Ville Evrard.
- •Suffering from an episode of catatonia according to the DSM-5 CRITERIA
- •Persistence of catatonia criteria according to DSM-5 after 24 hours of lorazepam treatment or contraindication to lorazepam or poor tolerance to lorazepam
- •Patient (or guardian) having given informed and written consent
- •Beneficiary of a social security plan
排除标准
- •Malignant catatonia
- •Pregnant or breastfeeding women
- •Patients with contraindications to tCDS, namely patients with a defibrillator or a pacemaker, brain stimulator, presence of intracranial metals, uncovered craniectomy or after trepanning.
结局指标
主要结局
Bush-Francis Catatonia Rating Scale (BFCRS)
时间窗: Day 6
The BFCRS is a comprehensive tool for diagnosing and assessing the severity of catatonic syndrome. The BFCRS was devised by Bush, Fink, Petrides, Dowling and Francis in 1996. This scale consists of the assessment of 23 symptoms, scored from 0 to 3. The total score of the BFCRS is the sum of the responses to the 23 items (minimum 0 - maximum 69). High scores reflect a severe disorder. Improvement is defined by a 30% decrease in BFCRS scores after 5 days of treatment (10 tDCS sessions)
次要结局
- Effectiveness of active tDCS vs sham: patients in remission after 20 sessions(every day from Day 1 to Day 14)
- Evolution of physiological parameters: Electrocardiography (ECG)(Baseline then every day from Day 1 to Day 14)
- Evolution of physiological parameters: Skin conductance level (SCL)(Baseline then every day from Day 1 to Day 14)
- Lorazepam treatment (mg/die)(At baseline then every day from Day 1 to Day 14)
- To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: Montgomery-Asberg depression scale (MADRS score)(At baseline, then at Day 1, Day 6, and from Day 11 to Day 14)
- Evolution of physiological parameters: brething system(Baseline then every day from Day 1 to Day 14)
- Bush-Francis Catatonia Rating Scale (BFCRS)(Day 14)
- Occurrence of catatonic syndrome complications(Every day from Day 1 to Day 14)
- Evolution of physiological parameters: Body temperature °C(Baseline then every day from Day 1 to Day 14)
- Evolution of physiological parameters: blood pressure (systolic pressure and a diastolic pressure mm HG)(Baseline then every day from Day 1 to Day 14)
- Percentage of patients requiring electroconvulsive therapy (ECT)(Every day from Day 1 to Day 14)
- To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: schizophrenia: . Positive and Negative Syndrome Scale (PANSS score)(At baseline, then at Day 1, Day 6, and from Day 11 to Day 14)
- To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: hypomanic or manic episode: Young Mania Rating Scale (YMRS score)(At baseline, then at Day 1, Day 6, and from Day 11 to Day 14)