Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS) - a Randomized, Placebo-controlled, Double-blind Trial of Transcranial Magnetic Stimulation and Group Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
研究概览
简要总结
Randomized, double-blind, placebo-controlled clinical trial testing the effects of 10 sessions of continuous theta burst stimulation and the effects of 16 sessions of social cognitive remediation therapy on gesture performance and nonverbal communication skills in schizophrenia
详细描述
The study focuses on nonverbal communication skills in schizophrenia. The trial will test, whether the combination of noninvasive brain stimulation and group psychotherapy will improve gesture performance and thus nonverbal communication in schizophrenia
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)
盲法说明
Assessments will be conducted by blind assessors. Participants will be blind to the type of psychotherapy and the type of rTMS administered
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
- 是
入选标准
- •Right-handed subjects
- •Ability and willingness to participate in the study
- •Ability to provide written informed consent
- •Informed Consent as documented by signature
- •schizophrenia spectrum disorders according to Diagnostic and statistical manual version 5 (DSM-5)
排除标准
- •Substance abuse or dependence other than nicotine
- •Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness.
- •Epilepsy or other convulsions
- •History of any hearing problems or ringing in the ears
- •Standard exclusion criteria for cerebral magnetic resonance imaging scanning and transcranial magnetic stimulation (TMS); e.g. metal implants, claustrophobia
- •Patients only: any transcranial magnetic stimulation (TMS) treatment in the past 3 months
- •Patients only: any cognitive remediation therapy in the past 2 years
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
change in gesture performance using the Test of Upper Limb Apraxia (TULIA)
时间窗: baseline, week 2, week 8, week 32
Test of upper limb apraxia (TULIA), recorded on video and scored according to manual. contains 48 items (gestures performed on verbal or visual instruction), total score ranges 0-240; higher scores indicate better performance.
次要结局
- change in Self evaluation of negative symptoms (SNS)(baseline, week 2, week 8, week 32)
- number of participants with treatment related adverse events as assessed with rating scale(week 2)
- change in the profile of nonverbal sensitivity (PONS)(baseline, week 2, week 8, week 32)
- change in functional capacity (UPSA brief)(baseline, week 2, week 8, week 32)
- change in neural activity during gesture planning using functional magnetic resonance imaging (fMRI)(baseline, week 8)
- change in Brief Negative Symptoms Scale (BNSS)(baseline, week 2, week 8, week 32)
- change in Social and occupational functioning (SOFAS)(baseline, week 2, week 8, week 32)
- change in the specific level of functioning assessment scale (SLOF)(baseline, week 2, week 8, week 32)