Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)
2026年8月13日 更新者：Xiaoming Du、The University of Texas Health Science Center, Houston
The aim of the study is to assess the treatment effects of deep active repetitive transcranial magnetic stimulation (rTMS) with H4 coil combined with cognitive training for improving frontal white matter microstructural integrity in patients with schizophrenia spectrum disorder (SSD).
研究概览
地位
尚未招聘
条件
详细说明
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.
rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. The efficacy of its combination with cognitive training in myelination modulation has not been evaluated.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiaoming Du, PhD
- 电话号码：443-882-9717
- 邮箱：Xiaoming.Du@uth.tmc.edu
研究联系人备份
- 姓名：Bhim M Adhikari
- 电话号码：713-486-2740
- 邮箱：bhim.m.adhikari@uth.tmc.edu
学习地点
-
-
Texas
-
Houston、Texas、美国、77054
- The University of Texas Health Science Center, Houston
-
接触：
- Xiaoming Du, PhD
- 电话号码：443-882-9717
- 邮箱：Xiaoming.Du@uth.tmc.edu
-
接触：
- Bhim Adhikari
- 电话号码：713-486-2740
- 邮箱：bhim.m.adhikari@uth.tmc.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 and not on anti-seizure medication(s) with sufficient dose.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Active rTMS Combined with Strong Cognitive Training
Participants will receive active H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks.
In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes.
The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
|
每次访问将进行三次访问，可在大约2周内进行10次访问。
相邻的TMS会话之间大约有30分钟的休息时间。
每个TMS会话大约需要3到4分钟才能完成。
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.
Strong cognitive training is intended to significantly enhance cognitive functions
|
|
实验性的：Active rTMS Combined with Weak Cognitive Training
Participants will receive active H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks.
In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes.
The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.
|
每次访问将进行三次访问，可在大约2周内进行10次访问。
相邻的TMS会话之间大约有30分钟的休息时间。
每个TMS会话大约需要3到4分钟才能完成。
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.
Weak cognitive training may yield only modest improvements in cognitive functions.
|
|
实验性的：Sham rTMS Combined with Strong Cognitive Training
Participants will receive sham H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks.
In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes.
In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
|
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.
Strong cognitive training is intended to significantly enhance cognitive functions
Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks.
There are about 30 minutes breaks between adjacent TMS sessions.
Each TMS session takes about 3 to 4 minutes to complete.
In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
|
|
实验性的：Sham rTMS Combined with Weak Cognitive Training
Participants will receive sham H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks.
In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes.
In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.
|
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.
Weak cognitive training may yield only modest improvements in cognitive functions.
Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks.
There are about 30 minutes breaks between adjacent TMS sessions.
Each TMS session takes about 3 to 4 minutes to complete.
In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
脑微结构完整性如白质分数各向异性（FA）值所示，如磁共振成像（MRI）所评估
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
将报告分数各向异性（FA）值。
FA值范围从0到1，较大的值表示更大的白质完整性。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
通过功能MRI评估的静息状态功能连通性（RSFC）值所示的大脑连通性（fMRI）
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
RSFC值将报告为Z评分，范围为-1至1，绝对值更大，表明大脑连接更强。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
通过脑电图评估（EEG）评估的不匹配负性表明的电生理反应（EEG）
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
不匹配的负值将在微伏（UV）中报告。
通过从平均响应对异常刺激的平均响应中减去对一组标准刺激的平均响应的平均响应，并在给定时间点中取出这种差异的幅度来衡量不匹配负性。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
贝克认知洞察量表所评估的认知洞察力
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
总分将报告，范围从15到60，得分较高，表明认知洞察力更高。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
抑郁状态和特质量表（DST）评估 - 状态
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
DST的状态分量量表的总得分将报告为0到72，得分较高，表明抑郁状态更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
抑郁状态和特征量表（DST）评估的抑郁症 - 特质
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
DST的特征子量表的总得分将报告为0到72，得分较高，表明抑郁症性状更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
卡尔加里抑郁量表评估的抑郁症
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
Calgary抑郁量表的总分数将报告为0到27，得分较高，表明抑郁症更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
贝克抑郁量清单评估的抑郁症
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
贝克抑郁量库存的总分数将报告为0到63，得分较高，表明抑郁症更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
受感知状态和特质量表所评估的感知 - 状态
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
感知状态和特质量表评估了音频和视觉体验感知的改变。
国家子量表的总分从0到96不等，更高的分数表明音频或视觉体验状态的变化更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
通过感知状态和特质量表评估的感知 - 特质
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
感知状态和特质量表评估了音频和视觉体验感知的改变。
性状子量表的总分数从0到96不等，更高的分数表明音频或视觉体验性状的变化更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
21个项目彼得妄想库存评估（PDI-21）所评估的妄想
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
总分将报告，范围为0到21，得分较高，表明妄想范围更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
情绪调节是通过情绪状态（POM）评估的
大体时间：基线之后的第1天，基线之后的第2天，基线之后的第3天，基线之后的第4天，基线之后的第5天，基线之后的第9天，基线之后的第10天，
|
总分将报告，范围为0到204，得分较高，表明情绪和情绪更高。
该结果度量将在10个治疗访问中的每一个中进行评估（基线后的第1天，基线后的第2天，基线后第3天，基线后第4天，基线后第5天，基线后第9天，基线后第9天，基线后第10天，基线后第10天）。
|
基线之后的第1天，基线之后的第2天，基线之后的第3天，基线之后的第4天，基线之后的第5天，基线之后的第9天，基线之后的第10天，
|
|
通过修订的幻觉量表（RHS）评估的幻觉
大体时间：基线之后的第1天，基线之后的第2天，基线之后的第3天，基线之后的第4天，基线之后的第5天，基线之后的第9天，基线之后的第10天
|
总分将报告，范围为0到13，得分较高，表明幻觉更大。
该结果度量将在10个治疗访问中的每一个中进行评估（大约是基线后的第1天，基线后的第2天，基线后第3天，基线后第4天，基线之后的第5天，基线后第9天，基线后第10天，基线后第10天，基线后第10天）。
|
基线之后的第1天，基线之后的第2天，基线之后的第3天，基线之后的第4天，基线之后的第5天，基线之后的第9天，基线之后的第10天
|
|
认知功能由基准共识认知电池（MCCB）的字母数字跨度子量表评估
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
总分将报告，范围为0到24，得分更高，表明认知功能更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
认知函数由基准共识认知电池的空间跨度量表（MCCB）评估
大体时间：基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
总分将报告，范围为0到32，得分较高，表明认知功能更大。
|
基线，访问6（基线之后约1周），请访问10（基线后约2周）
|
|
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)
大体时间：baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
|
Steady-state auditory evoked responses will be reported.
The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies.
The ratio will be obtained in a given timepoint.
|
baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xiaoming Du, PhD、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2029年5月1日
研究完成 (估计的)
2029年5月1日
研究注册日期
首次提交
2026年8月13日
首先提交符合 QC 标准的
2026年8月13日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月13日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.