Cerebellar Modulation of Cognition in Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- BACS Digit Sequence test
研究概览
简要总结
The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
详细描述
Psychotic disorders including schizophrenia, bipolar disorder, and related illnesses are severe, debilitating, and often fatal. Cognitive impairments in psychosis are among the leading predictors of disability and poor quality of life; despite this, there are no first-line interventions to target these symptoms.
This trial will test the hypothesis that cognitive performance in these disorders is modifiable and specifically that it can be modified non-invasively. Transcranial magnetic stimulation (TMS) is a neuromodulation technique that utilizes magnets to alter brain activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. In this study, we will use different forms of TMS to modulate a specific brain circuit and we will measure the outcomes of this circuit manipulation. These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The study design is a crossover design i.e. all participants will receive all three rTMS interventions (iTBS, cTBS, sham rTMS). The participant will be blinded to which intervention is happening on a given study visit. The order of these visits will be determined randomly for each participant.
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
- •Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)
- •Must be able to read, speak and understand English
- •Must be judged by study staff to be capable of completing the study procedures
- •Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.
排除标准
- •Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
- •Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
- •Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;
- •History of fainting spells of unknown or undetermined etiology that might constitute seizures
- •History of multiple seizures or diagnosis of epilepsy
- •Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease
- •Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- •Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)
- •Pacemaker
- •Implanted medication pump
- •Vagal nerve stimulator
- •Deep brain stimulator or transcutaneous electric nerve stimulation unit
- •Ventriculo-peritoneal shunt
- •Signs of increased intracranial pressure
- •Intracranial lesion
- •History of head injury resulting in prolonged loss of consciousness (>15minutes) or neurological sequelae
- •Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.
研究组 & 干预措施
continuous theta burst stimulation (cTBS)
Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning
干预措施: continuous theta burst stimulation (cTBS) (Device)
sham rTMS
Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning
干预措施: sham rTMS (Device)
Intermittent theta burst stimulation (iTBS)
Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning
干预措施: intermittant theta burst stimulation (iTBS) (Device)
结局指标
主要结局
BACS Digit Sequence test
时间窗: five minutes before TMS and four minutes after TMS on each of the three TMS visit days
The BACS digit sequence test is a test of working memory performance
BACS Symbol Coding test
时间窗: eight minutes before TMS and one minute after TMS on each of the three TMS visit days
The BACS Symbol coding test is a test of information processing speed
functional Magnetic Resonance Imaging
时间窗: fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days
resting-state (task free) functional connectivity
次要结局
未报告次要终点
研究者
Kathryn Eve Lewandowski
Associate Professor of Psychiatry, McLean Hospital
Mclean Hospital