跳至主要内容
临床试验/NCT05200182
NCT05200182Unknown不适用

fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Change in cortico-striatal connectivity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility
  • Minimum age : 18 Years
  • Maximum Age : 50 Years
  • Sex : women or men
  • Inclusion Criteria :
  • Normal Body Mass Index (18.5-25),
  • Right-handlers
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent

排除标准

  • Related to the study - Insufficient command of French
  • Related to Magnetic Resonance Imagine
  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia. Related to near infra Red spectroscopy
  • Hairs that do not allow proper near infra Red spectroscopy measurement upon ligh blockage
  • Minimum age : 18 Years
  • Maximum Age : 25 Years
  • Sex : women
  • Inclusion Criteria :
  • Normal BMI (18.5-25),
  • Right-handlers
  • Affiliated to a social security scheme
  • Having given a free, informed and written consent
  • Based on emotional overeating questionary : having emotional overeating episodes > 6 days in a month for at least one negative emotion
  • Exclusion Criteria :
  • Related to the study
  • Insufficient command of French
  • Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the Alcohol Use Disorders Identification Test questionnaires - excluded if score > 12 and "Car, Relax, Alone, Forget, Friends, Trouble" questionnaire - excluded if score> 1 " yes ")
  • Eating disorders ("sick, control, one stone, fat, food" questionnaire >2)
  • Food addiction (Yale Food Addiction Score 2.0, score >2
  • With psychoactive treatment
  • Digestive or gastric disorders
  • Related to magnetic resonance imaging
  • Implantable cardiac pacemaker or defibrillator;
  • Neurosurgical clips;
  • Cochlear implants;
  • Neural or peripheral stimulator;
  • Foreign orbital or brain metallic foreign bodies;
  • Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
  • Claustrophobia.
  • Related to near infraRed spectroscopy
  • - Hairs that do not allow proper near infraRed spectroscopy measurement upon ligh blockage

结局指标

主要结局

Change in cortico-striatal connectivity

时间窗: 4 weeks

Significant change in cortico-striatal connectivity as determined with resting state functional magnetic resonance imaging correlation coefficient between the first magnetic resonance imaging and the last magnetic resonance imaging visit

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验