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ObesityNCT04071717

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

A study testing NIRS neurofeedback in people with Obesity and Neurofeedback, run by Wu Wenjun-1 at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the efficacy of real-time fNIRS neurofeedback for regulating the brain cognitive function in obese individuals. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Neurofeedback
What is being tested?
NIRS neurofeedback
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
1 Jan 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Wenjun Wu, Master contact

+86 2984771141

wenjun104@126.com

Huaning Wang, Doctor contact

+86 2984771141

xskzhu@fmmu.edu.cn

China1 site, 1 recruiting

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

    Xi'an, Shaanxi

    Wenjun Wu, master, +86 2984771141, wenjun104@126.com

    Huaning Wang, doctor, +86 2984771141, xskzhu@fmmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
NIRS neurofeedback, Sham NIRS neurofeedback
Keywords
NIRS, fNIRS, Neurofeedback, Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIRS neurofeedbackBehavioural

    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 neurofeedbackBehavioural

    Sham NIRS neurofeedback

Study groups in NCT04071717
Study groupRoleWhat they receive
NIRS groupExperimentalParticipants with obesity, 12 sessions of NIRS feedback
Receives: Behavioral: NIRS neurofeedback
Sham NIRS groupSham comparatorParticipants with obesity, 12 sessions of sham NIRS feedback
Receives: Behavioral: Sham NIRS neurofeedback
Healthy control groupOtherHealthy participants, 12 sessions of NIRS feedback
Receives: Behavioral: NIRS neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Body Mass Index

    Change of the degree of obesity and health of the body

    Measured: Baseline, through study completion, an average of 6 weeks

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, through study completion, an average of 6 weeks

  2. 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.

    Measured: Baseline, through study completion, an average of 6 weeks

  3. 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.

    Measured: Baseline, through study completion, an average of 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04071717
Sponsor's protocol ID
KY20192043-F-1
Status last verified
Aug 2019
First submitted
26 Jul 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17071202

  • 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.

    PubMed 29866489

  • 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.

    PubMed 23797144

  • 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.

    PubMed 24507083

Questions about this trial

What is this clinical trial studying?

A study testing NIRS neurofeedback in people with Obesity and Neurofeedback, run by Wu Wenjun-1 at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenjun Wu, Master (+86 2984771141, wenjun104@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Body Mass Index (time frame: Baseline, through study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04071717, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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Clinical Trial NCT04071717 | AzTrials