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

NCT ID: NCT04071717

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Neurofeedback

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIRS group

Participants with obesity, 12 sessions of NIRS feedback

Group Type EXPERIMENTAL

NIRS neurofeedback

Intervention Type BEHAVIORAL

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 group

Participants with obesity, 12 sessions of sham NIRS feedback

Group Type SHAM_COMPARATOR

Sham NIRS neurofeedback

Intervention Type BEHAVIORAL

Sham NIRS neurofeedback

Healthy control group

Healthy participants, 12 sessions of NIRS feedback

Group Type OTHER

NIRS neurofeedback

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Sham NIRS neurofeedback

Sham NIRS neurofeedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xidian University

OTHER

Sponsor Role collaborator

Wu Wenjun-1

OTHER

Sponsor Role lead

Responsible Party

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Wu Wenjun-1

Clinical physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenjun Wu, Master

Role: STUDY_CHAIR

Xijing Hospital, The Air Force Medical University

Huaning Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital, The Air Force Medical University

Yi Zhang, professor

Role: PRINCIPAL_INVESTIGATOR

Xidian University

Locations

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

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjun Wu, Master

Role: CONTACT

+86 2984771141

Huaning Wang, Doctor

Role: CONTACT

+86 2984771141

Facility Contacts

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Wenjun Wu, master

Role: primary

+86 2984771141

Huaning Wang, doctor

Role: backup

+86 2984771141

References

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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.

Reference Type RESULT
PMID: 17071202 (View on PubMed)

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.

Reference Type RESULT
PMID: 29866489 (View on PubMed)

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.

Reference Type RESULT
PMID: 23797144 (View on PubMed)

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.

Reference Type RESULT
PMID: 24507083 (View on PubMed)

Other Identifiers

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KY20192043-F-1

Identifier Type: -

Identifier Source: org_study_id

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