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

Primary Purpose

Obesity, Neurofeedback

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIRS neurofeedback
Sham NIRS neurofeedback
Sponsored by
Wu Wenjun-1
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring NIRS, fNIRS, Neurofeedback, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Psychiatry, Xijing Hospital, The Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

NIRS group

Sham NIRS group

Healthy control group

Arm Description

Participants with obesity, 12 sessions of NIRS feedback

Participants with obesity, 12 sessions of sham NIRS feedback

Healthy participants, 12 sessions of NIRS feedback

Outcomes

Primary Outcome Measures

Change of Body Mass Index
Change of the degree of obesity and health of the body

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 26, 2019
Last Updated
August 25, 2019
Sponsor
Wu Wenjun-1
Collaborators
Xidian University
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1. Study Identification

Unique Protocol Identification Number
NCT04071717
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wu Wenjun-1
Collaborators
Xidian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Neurofeedback
Keywords
NIRS, fNIRS, Neurofeedback, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIRS group
Arm Type
Experimental
Arm Description
Participants with obesity, 12 sessions of NIRS feedback
Arm Title
Sham NIRS group
Arm Type
Sham Comparator
Arm Description
Participants with obesity, 12 sessions of sham NIRS feedback
Arm Title
Healthy control group
Arm Type
Other
Arm Description
Healthy participants, 12 sessions of NIRS feedback
Intervention Type
Behavioral
Intervention Name(s)
NIRS neurofeedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham NIRS neurofeedback
Intervention Description
Sham NIRS neurofeedback
Primary Outcome Measure Information:
Title
Change of Body Mass Index
Description
Change of the degree of obesity and health of the body
Time Frame
Baseline, through study completion, an average of 6 weeks
Secondary Outcome Measure Information:
Title
Change of Result of Willingness to Pay for Food
Description
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.
Time Frame
Baseline, through study completion, an average of 6 weeks
Title
Change of Result of Go/No-Go
Description
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.
Time Frame
Baseline, through study completion, an average of 6 weeks
Title
Working Memory
Description
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.
Time Frame
Baseline, through study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjun Wu, Master
Phone
+86 2984771141
Email
wenjun104@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huaning Wang, Doctor
Phone
+86 2984771141
Email
xskzhu@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjun Wu, Master
Organizational Affiliation
Xijing Hospital, The Air Force Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huaning Wang, Doctor
Organizational Affiliation
Xijing Hospital, The Air Force Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Zhang, professor
Organizational Affiliation
Xidian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjun Wu, master
Phone
+86 2984771141
Email
wenjun104@126.com
First Name & Middle Initial & Last Name & Degree
Huaning Wang, doctor
Phone
+86 2984771141
Email
xskzhu@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17071202
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. doi: 10.1016/j.amjsurg.2006.07.006.
Results Reference
result
PubMed Identifier
29866489
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.
Results Reference
result
PubMed Identifier
23797144
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.
Results Reference
result
PubMed Identifier
24507083
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.
Results Reference
result

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

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