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

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)

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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