Real-time Neurofeedback Regulating Brain Cognitive Function in Obese Individuals: a Near-infrared Spectroscopy-based Study.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change of Body Mass Index
Study Overview
Brief Summary
To determine the efficacy of real-time fNIRS neurofeedback for regulating the brain cognitive function in obese individuals.
Detailed Description
In the current study, 60 obese subjects will be recruited, and they were randomly classified into the group who will receive real neurofeedback and the group who will receive sham neurofeedback. Participants will receive the real-time neurofeedback for 12 times, 3 to 4 times a week, each time the real-time neurofeedback consists of 12 sessions of liftstone as the index reflecting the brain activity. Sham group will receive the identical neurofeedback.
All of the subjects will undergo magnetic resonance imaging scan, during which T1, diffusion tensor imaging, resting-state, and task fMRI data will be collected. For task Fmri scan, the participants will be asked to finish four cognitive task, including 2-Back working memory, Go/No-Go task, Willingness to Pay for Food, and Delay Discounting tasks. Clinical measurements including BMI, eating behavior, psychiatric status will be assessed. Those aforementioned examinations will be performed at before the neurofeedback, 6th times and the end of the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index (BMI) ≥ 25
- •18 to 65 years old
- •No severe mental disorders(depression; schizophrenia; bipolar disorder; etc.).
Exclusion Criteria
- •Severe dysfunction of heart, liver, kidney and hematopoietic system
- •Substance addiction
- •Patients who cannot be treated with fMRI or fNRIS neurofeedback
- •Those who take other weight loss drugs.
Arms & Interventions
NIRS group
Participants with obesity, 12 sessions of NIRS feedback
Intervention: NIRS neurofeedback (Behavioral)
Sham NIRS group
Participants with obesity, 12 sessions of sham NIRS feedback
Intervention: Sham NIRS neurofeedback (Behavioral)
Healthy control group
Healthy participants, 12 sessions of NIRS feedback
Intervention: NIRS neurofeedback (Behavioral)
Outcomes
Primary Outcomes
Change of Body Mass Index
Time Frame: Baseline, through study completion, an average of 6 weeks
Change of the degree of obesity and health of the body
Secondary Outcomes
- Working Memory(Baseline, through study completion, an average of 6 weeks)
- Change of Result of Willingness to Pay for Food(Baseline, through study completion, an average of 6 weeks)
- Change of Result of Go/No-Go(Baseline, through study completion, an average of 6 weeks)
Investigators
Wu Wenjun-1
Clinical physician
Xijing Hospital