Network Mediation of Experiential and Expressive Deficits in Psychotic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in Negative Symptom Severity
研究概览
简要总结
The main purpose of this study is to learn how transcranial magnetic stimulation (TMS) helps improve negative symptoms of schizophrenia. These 'negative symptoms' include anhedonia (the inability to enjoy things), low motivation, and decreased facial expression.
TMS is a noninvasive way of stimulating the brain. TMS uses a magnetic field to cause changes in activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study we will be stimulating the brain to learn more about how TMS may improve these symptoms from schizophrenia.
详细描述
This study proposes to test the hypothesis that the medication refractory experiential (anhedonia and amotivation) and expressive deficits named 'negative symptoms' are mediated by network pathophysiology and the functional connectivity of a cerebellar-prefrontal cortical network mediates the severity of these deficits. To accomplish this participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who demonstrate negative symptoms despite stable outpatient treatment.
Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of negative symptom severity. These assessments include reporter-based measures such as the Positive And Negative Syndrome Scale (PANSS) as well as quantitative tests of amotivation/anhedonia and diminished expressivity.
Participants will then undergo an MRI scan that includes structural and resting state functional magnetic resonance imaging (rsfMRI). These rsfMRI images will be used to isolate individual resting-state networks for targeting of rTMS modulation.
Participants will then undergo five days of twice daily rTMS sessions in one of the four arms of this study.
One week after the last rTMS session, Participants will undergo follow-up MRI imaging and the same assessments described above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status. Blinding codes are used to determine which side of an active/passive Magpro coil (cool B65 A/P, Magventure A/S, Denmark) is used for stimulation.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-55 years
- •At pre-visit screening (see attached phone screening questionnaire): participants must report that they have been given a diagnosis of schizophrenia or schizoaffective disorder by a mental health professional
- •Must be able to read, speak, and understand English
- •Must be judged by study staff to be capable of completing the study procedures
- •Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V criteria and confirmed by SCID
- •Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their mediation regimens
排除标准
- •DSM-V intellectual disability
- •substance use disorder within the past three months
- •Ambidexterity (the EEfRT task assumes participants are not ambidextrous)
- •Any history of progressive or genetic neurological disorder (e.g. Parkinson's disease, multiple sclerosis, tubular sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
- •History of head trauma resulting in any loss of consciousness (>15 minutes) or neurological sequelae
- •Current history of poorly controlled headaches including chronic medication for migraine prevention
- •History of fainting spells of unknown or undetermined etiology that might constitute seizures
- •History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- •Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- •Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- •Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
- •All female participants of child bearing age will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study
- •Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.
- •Any changes in medications or hospitalizations within the past 30 days.
- •Subjects who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit
研究组 & 干预措施
Active DLPFC rTMS
Active repetitive Transcranial Magnetic Stimulation (rTMS) with iTBS pattern to the right DLPFC at 80% of active motor threshold.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham DLPFC rTMS
Sham repetitive Transcranial Magnetic Stimulation (rTMS) with iTBS pattern to the right DLPFC
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Active cerebellum rTMS
Active repetitive Transcranial Magnetic Stimulation (rTMS) with iTBS pattern to the cerebellum at 100% of active motor threshold.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham cerebellum rTMS
Sham repetitive Transcranial Magnetic Stimulation (rTMS) with iTBS pattern to the cerebellum
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Change in Negative Symptom Severity
时间窗: Before treatment (Baseline) and 1 week post treatment
We will evaluate the effect of sham vs active rTMS on The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Symptom total score. This score is the sum of seven questions on the PANSS questionnaire (named N1-N7). Each question is scored from 1-7 for a total score per individual ranging from 7-49. On this scale higher numbers indicate great symptomology
次要结局
- Change in Cerebellar - Prefrontal Functional Connectivity(Before treatment (Baseline) and 1 week post treatment)
- Change in Auditory Hallucination Severity(Before treatment (Baseline) and 1 week post treatment)
研究者
Roscoe Brady
Assistant Professor of Psychiatry
Beth Israel Deaconess Medical Center