fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
报名条件(概要)
- 年龄:18 Years – 50 Years
- 性别:不限
- 健康志愿者:接受
完整入排标准请以官方页面为准。
开展国家/地区
France
药品与企业信息
the neurofeedback protocol will last 15 minutes per session, and during each session, the volunteer will have to increase the brain activity of his/her dorsolateral prefrontal cortex using a visual gauge representing the "activity level" of his/her own dorsolateral prefrontal cortex. No specific instructions will be given to the volunteer so that he/she can develop his/her own internal strategy to increase this "activity level".
the participants will receive the same instruction but will be shown a random signal
an examination and oral swab for oral microbiota analysis will be performed by a dentist
questionnaires for pre-intervention behavioral characterization
characterize the brain function of volunteers by resting-state fMRI
Volunteers will also be equipped with an MRI-compatible electro-gastrogram device to correlate gastric signals with brain activity during rsMRI acquisition.
an emotional Stroop task adapted to food and body image representation
Delay discount task
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement研究机构/其他
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Recently, imaging modalities, such as magnetic resonance imaging (MRI) and electro-encephalography (EEG), have been adapted in order to perform neurofeedback consisting on presenting the brain activity instantaneously to the participant, that give him the possibility to modify this activity by his own mean. Neurofeedback has already shown some efficacy, either with explicit or implicit instruction. Compared with functional MRI (fMRI), functional near infra-red spectroscopy (fNIRS) is easy to handle, less expensive, and does not require a lying position. fNIRS is consequently more adapted for repeated acquisitions. Neurofeedback has already shown some promising results for neurological and psychiatric diseases. For mental states and emotion regulation, neurofeedback targeting the prefrontal cortex (PFC) has also shown promising outcomes. In this project, the investigators want to assess the effect of neurofeedback targeting the dorsolateral PFC (dlPFC) in a population of young adult women presenting emotional overeating. The investigators aim to improve the cognitive control and to reduce the episodes of emotional overeating in order to prevent the occurrence of subsequent pathologies. The intervention effect will be characterized with: (i) fMRI in order to evaluate the effect on cognitive control (with resting state fMRI or rsMRI) and on the reward system; (II) questionaries directly and one month after intervention in order to assess the behavioral effect. Besides an expected effect on emotional overeating, the investigators will evaluate whether an improvement of cognitive control can also promote positive effect on other behavioral traits that could lead to some pathologies such as food addiction. As a prerequisite to this study on emotional overeating (study B), the investigators will firstly validate on healthy subjects (study A) a reward anticipation fMRI task, which will be further used in study A in order to characterized the effect of neurofeedback on the reward system.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Loïc JACOBloic.jacob@chu-rennes.fr0299282555
- Nicolas COQUERY, PhDnicolas.coquery@inrae.fr
研究中心联系方式
- Chu Rennes - PontchaillouRennes,France
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating ClinicalTrials.gov Identifier: NCT05200182 Sponsor: Rennes University Hospital Investigational product: Neurofeedback with functional near infra-red spectroscopy, Sham Neurofeedback, oral microbiota collection, Questionnaires, resting-state fMRI About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating 试验编号:NCT05200182 申办方:Rennes University Hospital 研究药物:Neurofeedback with functional near infra-red spectroscopy、Sham Neurofeedback、oral microbiota collection、Questionnaires、resting-state fMRI 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。