Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI)
研究概览
简要总结
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
详细描述
Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.
The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. Its efficacy in myelination modulation has not been evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ages between ages 18-60 years
- •Ability to give written informed consent (age 18 or above)
- •Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
排除标准
- •Inability to sign informed consent.
- •Any history of seizures.
- •Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria).
- •Taking > 400 mg clozapine/day.
- •Failed TMS screening questionnaire.
- •Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- •A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
- •Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test).
- •History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- •Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- •Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality).
- •For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.
研究组 & 干预措施
Active rTMS
Participants in this group will receive active H-coil delivered rTMS.
干预措施: active H-coil delivered rTMS (Device)
结局指标
主要结局
Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI)
时间窗: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Fractional anisotropy (FA) values will be reported. FA values range from 0 to 1 with larger values indicating greater white matter integrity.
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)
时间窗: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
次要结局
- Depression as assessed by the Calgary Depression Scale(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Emotion regulation as assessed by the Profile of Mood States (POMS)(day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline)
- Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Cognitive insight as assessed by the Beck Cognitive Insight Scale(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Perception as assessed by the Perception State and Trait Scale - state(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21)(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Hallucination as assessed by the Revised Hallucinations Scale (RHS)(day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline)
- Cognitive function as assessed by the Spatial Span subscale of the MATRICS consensus cognitive battery (MCCB)(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Depression as assessed by the Depression State and Trait Scale (DST) - trait(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Perception as assessed by the Perception State and Trait Scale - trait(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Depression as assessed by the Depression State and Trait Scale (DST) - state(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Depression as assessed by the Beck Depression Inventory(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
- Cognitive function as assessed by the Letter-Number Span subscale of the MATRICS consensus cognitive battery (MCCB)(baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline))
研究者
Xiaoming Du
Assistant Professor
The University of Texas Health Science Center, Houston