Treating Social Cognition Impairments in Patients With Schizophrenia With Repetitive Transcranial Magnetic Stimulation (Theta-Burst; TBS); a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- V-LIS total score
研究概览
简要总结
The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical variables, cognitive and psychomotor most sensitive to treatment, to estimate the most sensitive treatment target, assess tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the brain a multimodal imaging study and compare the imaging variables (resting network, Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients before treatment and healthy subjects.
详细描述
The language understanding of other people is based on linguistic decoding mechanisms (phonological, semantic, syntactic ...) but also more on subtle mechanisms for the recognition of emotions and intentions. Interact with another one requires understanding its language but also to infer emotions and intentions. There are patients with schizophrenia suffering from social cognition disorders that impair social interactions; These patients often have difficulty in extracting the non-verbal emotional content of language and have difficulty inferring the thoughts and intentions of others. Recently, we have suggested a link between such deficits and the hypofunction of the medial prefrontal cortex.
Transcranial magnetic stimulation is a noninvasive neuromodulation technique that increases or decreases the focal cortical excitability depending on stimulation parameters. This technique is now commonly used as a therapeutic tool. It has been tried with some success in patients with schizophrenia in some indications:
- To reduce the auditory verbal hallucinations stimulating the temporal cortex
- More rarely, to reduce the negative symptoms stimulating the dorsolateral prefrontal cortex So far, the medial prefrontal cortex was not considered as a possible target as the scalp to cortex distance prevent from using conventional stimulation coils. Recently new coils have been developed that permit stimulation of deeper cortical regions.
We hypothesize that the use of transcranial magnetic stimulation with a theta burst intermittent protocol known to increase the cortical excitability and aiming the medial prefrontal cortex with a special antenna will improve social interaction capabilities of schizophrenic patients.
This ambitious and innovative assumption shall be first supported by a study of feasibility which is the subject of this trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
- •less than 20 years of disease duration
- •Having signed a written informed consent
- •LIS score > 15 or negative PANSS score > 15
排除标准
- •Any change in psychotropic drugs (antidepressants, antipsychotics or mood stabilizers) during the two months preceding the inclusion
- •Pregnant or breastfeeding women
- •Subjects with a neurological condition or with epilepsy
- •Subjects with a counter-indication to MRI or Transcranial stimulation (electronic or metal implants)
- •Subjects that refuse to wear earplugs during MRI
研究组 & 干预措施
Healthy subjects
Multimodal imaging data acquisitions Clinical data acquisitions
TBS-MPC
- Intervention with active TBS aiming Medial Prefrontal Cortex in 6 patients with schizophrenia
- Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Continuous actimetry acquisition
干预措施: Active TBS (Device)
TBS-CPDLF
- Intervention with active TBS aiming Dorsolateral Prefrontal Cortex in 6 patients with schizophrenia
- Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Continuous actimetry acquisition
干预措施: Active TBS (Device)
TBS-Sham
- Intervention with Sham TBS in 8 patients with schizophrenia
- Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition
- Continuous actimetry acquisition
干预措施: Sham TBS (Device)
结局指标
主要结局
V-LIS total score
时间窗: change from baseline in V-LIS total score compared to 30 days after the end of the treatment
次要结局
- P50 wave amplitude(change in baseline P50 amplitude compared to immediately after the end of the treatment)
- GLX ratio(change in baseline GLX ratio measured in MRSI compared to 30 days after the end of the treatment)
- Motor activity(change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment)