Interventional Triple-negative Placebo-controlled Personalized Prospective Study "Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of onset of the primary response
研究概览
简要总结
Evaluation effectiveness and safety of TMS in subjects with catatonia
详细描述
Non-pharmacological strategies for influencing brain structures show great potential, particularly transcranial magnetic stimulation (TMS), which allows targeting specific areas of the brain and activating neuroplastic processes that contribute to the restoration of lost functions. According to study hypothesis, therapy for catatonia is possible through the stimulation of the dorsolateral prefrontal cortex (DLPFC), given its accessibility and role in the syndrome's development because. It has been established that a key process in the pathogenesis of catatonia is the disruption of the structural-functional connectivity and activity of several regions within the fronto-temporal network
The design of the study involves following stages:
- diagnostic stage and randomization
- two personalized stimulation protocols (high- and low-frequency delivery of magnetic pulses) with placebo control
- initial analysis of the effectiveness of protocols after 10 sessions of stimulation, followed by the transfer of all patients, including the placebo group to the most effective protocol.
- the stage of active neuromodulation of 20 sessions (4 weeks) according to the protocol of effective stimulation regiment
- final analysis of the effectiveness after 20 sessions of TMS, as well as after 1 and 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified diagnosis of schizophrenic or affective spectrum (schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
- •Patient's ability (possibly accompanied by caregivers) to undergo diagnostic and therapeutic procedures;
- •The presence of residual catatonia in the form of such psychomotor anomalies as:
- •disorganisation of thinking with speech disturbance with verbigerations and/or sperrungs
- •hypo- and hyperkinetic psychomotor phenomena;
- •substupor without disturbance of consciousness;
- •elective mutism;
- •echo phenomena (echolalia and/or echopraxia);
- •phenomena of "wax flexibility"
- •speech and behavioral stereotypy
- •pathetic exaltation phenomena
- •the phenomenon of irritative asthenia
- •dysuric phenomena (monotonous activity and rigidity of affect)
排除标准
- •patient's refusal to participate in the study
- •acute hallucinatory-delusional symptoms
- •suicide risk
- •a patient taking prohibited therapy products
- •neuroleptic complications of antipsychotic therapy
- •irritative asthenia
- •dysuric phenomena by the type of monotonous activity and rigidity of affect
结局指标
主要结局
The rate of onset of the primary response
时间窗: 6 months
Reduction of points on the BPRS and NCRS scales to 70% of the initial
The number of patients with a positive effect of therapy
时间窗: 6 months
Reduction of the total score on BFCRS and NCRS by at least 50%
The number of patient with the improvement
时间窗: 6 months
The total score for BFCRS and NCRS is no more than 3 points
次要结局
未报告次要终点