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

W

Wu Wenjun-1

Status

Unknown

Conditions

Neurofeedback
Obesity

Treatments

Behavioral: NIRS neurofeedback
Behavioral: Sham NIRS neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT04071717
KY20192043-F-1

Details and patient eligibility

About

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

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

NIRS group
Experimental group
Description:
Participants with obesity, 12 sessions of NIRS feedback
Treatment:
Behavioral: NIRS neurofeedback
Sham NIRS group
Sham Comparator group
Description:
Participants with obesity, 12 sessions of sham NIRS feedback
Treatment:
Behavioral: Sham NIRS neurofeedback
Healthy control group
Other group
Description:
Healthy participants, 12 sessions of NIRS feedback
Treatment:
Behavioral: NIRS neurofeedback

Trial contacts and locations

1

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Central trial contact

Wenjun Wu, Master; Huaning Wang, Doctor

Data sourced from clinicaltrials.gov

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