NCT04071717

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

July 26, 2019

Last Update Submit

August 25, 2019

Conditions

ObesityNeurofeedback

Keywords

NIRSfNIRSNeurofeedbackObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Working Memory

    Baseline, through study completion, an average of 6 weeks

Study Arms (3)

NIRS group

EXPERIMENTAL

Participants with obesity, 12 sessions of NIRS feedback

Behavioral: NIRS neurofeedback

Sham NIRS group

SHAM COMPARATOR

Participants with obesity, 12 sessions of sham NIRS feedback

Behavioral: Sham NIRS neurofeedback

Healthy control group

OTHER

Healthy participants, 12 sessions of NIRS feedback

Behavioral: NIRS neurofeedback

Interventions

NIRS neurofeedbackBEHAVIORAL

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.

Healthy control groupNIRS group
Sham NIRS neurofeedbackBEHAVIORAL

Sham NIRS neurofeedback

Sham NIRS group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Xijing Hospital, The Air Force Medical University

Xi'an, Shaanxi, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17071202RESULT

  • 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.

    PMID: 29866489RESULT

  • 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.

    PMID: 23797144RESULT

  • 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.

    PMID: 24507083RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wenjun Wu, Master

    Xijing Hospital, The Air Force Medical University

    STUDY CHAIR

  • Huaning Wang, Doctor

    Xijing Hospital, The Air Force Medical University

    PRINCIPAL INVESTIGATOR

  • Yi Zhang, professor

    Xidian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjun Wu, Master

CONTACT

+86 2984771141wenjun104@126.com

Huaning Wang, Doctor

CONTACT

+86 2984771141xskzhu@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical physician

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 28, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)