Clinical trial NCT04071717: Real-time NIRS Neurofeedback Regulating Brain Cognitive Function in Obese Individuals
Official title: Real-time Neurofeedback Regulating Brain Cognitive Function in Obese Individuals: a Near-infrared Spectroscopy-based Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Neurofeedback
Keywords: NIRS
fNIRS
Neurofeedback
Obesity
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Xidian University
First posted: 2019-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≥ 25
2. 18 to 65 years old
3. No severe mental disorders(depression; schizophrenia; bipolar disorder; etc.).

Exclusion Criteria:

1. Severe dysfunction of heart, liver, kidney and hematopoietic system
2. Substance addiction
3. Patients who cannot be treated with fMRI or fNRIS neurofeedback
4. Those who take other weight loss drugs.

Primary outcomes:
measure: Change of Body Mass Index
timeFrame: Baseline, through study completion, an average of 6 weeks
Secondary outcomes:
measure: Change of Result of Willingness to Pay for Food
timeFrame: Baseline, through study completion, an average of 6 weeks
measure: Change of Result of Go/No-Go
timeFrame: Baseline, through study completion, an average of 6 weeks
measure: Working Memory
timeFrame: Baseline, through study completion, an average of 6 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Psychiatry, Xijing Hospital, The Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital, The Air Force Medical University
name: Wenjun Wu, Master
role: STUDY_CHAIR
affiliation: Xijing Hospital, The Air Force Medical University
name: Huaning Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xidian University
name: Yi Zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Watanabe T, Sasaki Y, Shibata K, Kawato M. Advances in fMRI Real-Time Neurofeedback: (Trends in Cognitive Sciences 21, 997-1010, 2017). Trends Cogn Sci. 2018 Aug;22(8):738. doi: 10.1016/j.tics.2018.05.007. Epub 2018 Jun 1. No abstract available.
citation: Schwartz DH, Leonard G, Perron M, Richer L, Syme C, Veillette S, Pausova Z, Paus T. Visceral fat is associated with lower executive functioning in adolescents. Int J Obes (Lond). 2013 Oct;37(10):1336-43. doi: 10.1038/ijo.2013.104. Epub 2013 Jun 5.
citation: Diamantis T, Apostolou KG, Alexandrou A, Griniatsos J, Felekouras E, Tsigris C. Review of long-term weight loss results after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2014 Jan-Feb;10(1):177-83. doi: 10.1016/j.soard.2013.11.007. Epub 2013 Nov 21.