Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
2022年2月28日 更新者：University of Minnesota
The purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tDCS).
tDCS is a new technique used to stimulate the brain.
The investigators believe that it may help to change brain function in individuals with anorexia nervosa.
The brain stimulation occurs outside the head.
The tDCS procedure involves applying a small amount of electrical current across the scalp, for a short period of time.
This small electrical current is able to change the electrical activity inside areas of the brain.
In the current study, the investigators will ask participants to complete computer-based brain training sessions.
While participants do the brain training exercises, they will receive either real tDCS for "sham" tDCS.
"Sham" tDCS means that participants might feel sensations like tingling or vibrations from the tDCS machine, but will not actually receive the electrical current.
Investigators will also ask participants to complete several tests to assess changes in brain function.
The information gained from this study will help investigators to understand how tDCS could be used to improve brain function and learning in individuals with anorexia nervosa.
研究概览
地位
撤销
研究类型
介入性
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。
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18+ years
- Documented enrollment in residential-level treatment at The Emily Program and meeting criteria for AN (BMI <18.5).
- Participant must be capable of giving informed consent, based on University of California San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC)39 risk assessment, which has been uploaded to ETHOS.
- Sufficient spoken English so as to be able to comprehend testing procedures.
Exclusion Criteria:
- Substance abuse in the participant
- Neurological condition or other developmental disorder
- Serious psychiatric disorder known to affect brain functioning and cognitive performance
- Medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (The Emily Program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study).
- MRI contraindication [based on Center for Magnetic Resonance Research (CMRR) prescreening protocol]
- tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active tDCS
Participants will receive 10 sessions of active tDCS + cognitive training.
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Transcranial direct current stimulation, involving low-levels of electrical stimulation applied to the right and left DLPFC will be used in conjunction with cognitive training for 46 minutes.
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假比较器：Sham tDCS
Participants will receive 10 sessions of sham tDCS + cognitive training.
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Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
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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 |
|---|---|---|
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and rate of treatment dropout in treatment-seeking adults with AN receiving treatment in a residential treatment program for eating disorders.
大体时间：Through study completion, an average of 1 year.
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Treatment-related adverse events will be assessed by CTCAE v4.0 criteria.
Participant dropout will be examined in effort to evaluate whether individuals with AN will tolerate the procedures and remain in the study.
This will be evinced by less than 20% dropout over the course of active tDCS and cognitive training.
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Through study completion, an average of 1 year.
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Change from Baseline to End of Treatment Set-Shifting Task Performance Following 10-session tDCS + Cognitive Training Intervention Protocol.
大体时间：Through study completion, an average of 1 year.
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Changes in cognitive flexibility will be assessed by examining differences between baseline and end of treatment performance on reversal learning task.
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Through study completion, an average of 1 year.
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Change from Baseline to End of Treatment Resting State and Task-based Functional Magnetic Resonance Imaging (fMRI) Activation during Reversal Learning Task Following 10-session tDCS + Cognitive Training Intervention Protocol.
大体时间：Through study completion, an average of 1 year.
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Changes in brain circuitry assessed during resting state and task-based fMRI will be assessed to examine whether active tDCS is associated with greater change in associated circuitry, as compared with sham tDCS.
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Through study completion, an average of 1 year.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment
大体时间：Through study completion, an average of 1 year.
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Change in eating disorder psychopathology, measured by the EDE, will be evaluated over the course of a 10-session tDCS + cognitive training intervention to determine whether tDCS is associated with significant change in eating pathology among individuals with Anorexia Nervosa.
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Through study completion, an average of 1 year.
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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：Kelvin O Lim, MD, PhD、University of Minnesota
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 (实际的)
2019年8月30日
初级完成 (实际的)
2021年12月31日
研究完成 (实际的)
2021年12月31日
研究注册日期
首次提交
2018年7月24日
首先提交符合 QC 标准的
2018年8月22日
首次发布 (实际的)
2018年8月27日
研究记录更新
最后更新发布 (实际的)
2022年3月14日
上次提交的符合 QC 标准的更新
2022年2月28日
最后验证
2022年2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.
主动 tDCS的临床试验
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University of Minnesota撤销
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Universite du Littoral Cote d'Opale招聘中
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The Hospital for Sick Children完全的
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Universitat Pompeu FabraNeuroelectrics Corporation未知
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University of ChicagoNational Institute on Aging (NIA)完全的
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Nanyang Technological UniversityMinistry of Education, Singapore; National Institute of Education, Singapore尚未招聘老化 | 执行功能 | 经颅直流电刺激 (tDCS) | 经颅电刺激