NCT07290738招募中不适用
TMS for Negative Symptoms in Schizophrenia Spectrum Disorders
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月13日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in blood-brain barrier (BBB) water exchange rate at AG obtained from MRI scan
研究概览
简要总结
The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) applied to angular gyrus (AG) will improve negative symptoms and/or other psychosis symptoms in schizophrenia spectrum disorders (SSD) patients compared with prefrontal cortex (PFC) or sham.
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
- Double (Participant, Outcomes Assessor)
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
- •Ability to give written informed consent
- •Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above
- •Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
- •Have negative symptoms as determined by BNSS score of 20 or more.
- •Agrees to provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided service to the subject within two years of study enrollment
排除标准
- •Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
- •Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- •Failed TMS screening questionnaire.
- •Significant alcohol or other drug use (substance dependence within the recent months) or positive urine toxicology screen for substance not prescribed other than nicotine or marijuana dependence.
- •Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, Central nervous System (CNS)infection or tumor, other significant brain neurological conditions.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- •History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- •0 Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- •Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
- •Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e. answers YES to Question 2 and NO to Question 6 (Moderate risk); or answers YES to Questions 3 (Moderate risk), 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
- •History (or family history) of deep vein thrombosis.
研究组 & 干预措施
AG TMS
Experimental
干预措施: TMS (Device)
PFC sham
Sham Comparator
干预措施: sham (Device)
AG Sham
Sham Comparator
干预措施: sham (Device)
PFC TMS
Active Comparator
干预措施: TMS (Device)
结局指标
主要结局
Change in blood-brain barrier (BBB) water exchange rate at AG obtained from MRI scan
时间窗: baseline (before treatment visit 1), midpoint (after treatment visit 10; about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)
次要结局
- Change in Negative symptoms as assessed by the Brief Negative Symptom Scale (BNSS)(at baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Positive symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS)(at baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Cognitive function as assessed by Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Working memory as assessed by the Number Span test(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Working memory as assessed by the Wechsler Memory Scale-Third Edition (WMS-III): Spatial Span(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Cognitive function as assessed by the Category Fluency Test: Animal naming (Fluency)(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Cognitive function as assessed by the Rey-Osterrieth Complex Figure Test(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Cognitive function as assessed by the Bell Lysaker Emotion Recognition Task(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Cognitive function as assessed by the Hinting Task(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Depression as assessed by the Calgary Depression Scale(t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Resting state functional connectivity between AG and PFC assessed by functional MRI (fMRI)(at baseline (before treatment visit 1), midpoint (after treatment visit 10; about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Activity level (number of steps per day) as assessed by smart wristwatch(from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Location (number of unique places visited)as assessed by smart wristwatch(from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Sleep (number of hours slept per day) as assessed by smart wristwatch(from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Speech (pitch, intonation, pause) as assessed by video recording of speech(baseline, after treatment visit 10 (about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in facial expression (neutral, positive, and negative facial features) as assessed by video recording of speech(baseline, after treatment visit 10 (about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Electrophysiological responses as indicated by mismatch negativity as measured by electroencephalography (EEG)(baseline (before treatment visit 1) and end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
- Change in Electrophysiological response as indicated by steadystate auditory evoked responses from electroencephalography recording (EEG)(baseline (before treatment visit 1) and end of acute treatment (after treatment visit 20; about 4 weeks from baseline))
研究者
Xiaoming Du
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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