Real-time NIRS Neurofeedback Regulating Brain Cognitive Function in Obese Individuals

Obesity Clinical Trial

Official title:

Real-time Neurofeedback Regulating Brain Cognitive Function in Obese Individuals: a Near-infrared Spectroscopy-based Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071717
• Other study ID #: KY20192043-F-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Xijing Hospital
• Contact: Wenjun Wu, Master
• Phone: +86 2984771141
• Email: wenjun104[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy of real-time fNIRS neurofeedback for regulating the brain cognitive function in obese individuals.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurofeedback
• Obesity

Intervention

Behavioral:
• NIRS neurofeedback
Neurofeedback as a treatment for people which can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
• Sham NIRS neurofeedback
Sham NIRS neurofeedback

Locations

Country	Name	City	State
China	Department of Psychiatry, Xijing Hospital, The Air Force Medical University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Wu Wenjun-1	Xidian University

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View Citation

Samuel I, Mason EE, Renquist KE, Huang YH, Zimmerman MB, Jamal M. Bariatric surgery trends: an 18-year report from the International Bariatric Surgery Registry. Am J Surg. 2006 Nov;192(5):657-62. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Body Mass Index	Change of the degree of obesity and health of the body	Baseline, through study completion, an average of 6 weeks
Secondary	Change of Result of Willingness to Pay for Food	The Willingness to Pay for Food (WTP) task is designed to evaluate obese subjects' cognitive decision ability regarding food. Participants are provided with four response options (i.e. 5¥,30¥,70¥,100¥) that can be selected to purchase a series of visually presented food items (HC, High-calorie food and LC, Low-calorie food).The task will record subjects' response time (RT) and money values selected for each presented food items. Mean response time and mean money values selected for HC food and LC food will be calculated and reported respectively. Shorter RT and bigger more money values selected for LC food represents better outcome. Shorter RT and bigger more money values selected for HC food represents worse outcome.	Baseline, through study completion, an average of 6 weeks
Secondary	Change of Result of Go/No-Go	The Go/No-Go task is designed to evaluate subjects' inhibitory control capacity.; Participants were instructed to press a button as quickly and accurately as possible in response to go trials and to refrain from responding to no-go trials. The current task involved two conditions (Go-condition and NoGo-condition). The task will record subjects' response time (RT) and whether correct for each trial response. Task response accuracy, response time, omission error rate (OE, %) and commission error rate (CE, %) will be calculated and reported. Omission error rate (OE, %) was calculated by dividing the total number of non-responses to go-items by the total number of go-trials. Commission error rate (CE, %) was calculated by dividing the total number of incorrect responses to no-go trials by the total number of no-go trials. Higher accuracy, lower RT, lower OE and lower CE represent better treatment outcome.	Baseline, through study completion, an average of 6 weeks
Secondary	Working Memory	The Working Memory task (WM) is designed to evaluate obese subjects' short-term memory. Subjects performed food pictures variant version of working memory (n-back) tasks, which were block designed. In 0-back blocks (including 0-back block for HC (High-calorie food), LC (Low-calorie food) and Neutral pictures respectively), subjects were required to identify a single prespecified picture. Briefly, subjects were asked to press a button as quickly to indicate whether a picture presented on a screen matched the picture previously presented.The task will record subjects' response time (RT) and accuracy for each n-back block. Subjects' 2-back response time and accuracy for HC and LC will be calculated and reported. Shorter RT and higher accuracy of 2-back for HC and LC represents better outcome. Longer RT and lower accuracy of 2-back for HC and LC represents worse outcome.	Baseline, through study completion, an average of 6 weeks