STUDY PROTOCOL article
Front. Hum. Neurosci.
Sec. Brain Imaging and Stimulation
Volume 19 - 2025 | doi: 10.3389/fnhum.2025.1698351
This article is part of the Research TopicCognitive enhancement by brain stimulation techniquesView all 6 articles
Clinical study of wearable low-intensity pulsed ultrasound treatment in the improvement of executive function in obesity(the SLITE trial): protocol for a single -centre, double-blind, randomized controlled trial
Provisionally accepted
- 1Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital Department of Ultrasound in Medicine, Shanghai, China
- 2Shanghai Center for Brain Science and Brain-Inspired Technology, Shanghai, China
- 3Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiao Tong University Department of Endocrinology and Metabolism, Shanghai, China
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Introduction Obesity is a global health crisis associated with significant physical and cognitive impairments, particularly in executive function. Impaired executive function exacerbates unhealthy eating behaviors and hinders effective weight management. Non-invasive neuromodulation techniques like transcranial direct current stimulation and transcranial magnetic stimulation have demonstrated potential in improving executive function and assisting in weight reduction but face limitations in accessibility and efficacy. Low-intensity pulsed ultrasound (LIPUS) represents an emerging neuromodulation technique distinguished by its non-invasive application and superior spatial resolution, facilitating targeted modulation of cortical activity and neural excitability with high precision. This study aims to explore the efficacy of LIPUS on executive function in obesity. Methods and analysis This study adopts a prospective, single-centre, double-blind, randomized controlled design. A total of 44 participants diagnosed with obesity (BMI ≥28 kg/m²) will be enrolled and equally assigned to the LIPUS and sham groups. The LIPUS group will receive pulsed therapeutic ultrasound for 4 weeks, while the sham group will receive placebo treatment using a device delivering no therapeutic ultrasound. Both groups will undergo assessments at baseline and after 4 weeks, with the primary outcome being the change in reaction time on the food Go/No-go task. Secondary outcomes include changes in body weight, BMI, food cravings (measured by the Food Craving Questionnaire-Trait and State versions), food-eating behavior (measured by the Visual Analog Scale and the Dutch Eating Behavior Questionnaire), and cognitive performance as assessed by the Stroop test. Additional neuroimaging assessments will
Keywords: Obesity, Low-intensity pulsed ultrasound, Executive Function, Neuromodulation, randomized controlled trial
Received: 03 Sep 2025; Accepted: 10 Oct 2025.
Copyright: © 2025 Xiong, Zhong, Zhang, Xie, Hao, Zheng and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yuanyi Zheng, zhengyuanyi@sjtu.edu.cn
Fengjing Liu, liufengjing@shsmu.edu.cn
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.