Endoscopically Implanted, Self-Powered, Vagal Nerve Stimulation Device: Experimental Feasibility Study.

Area of Science:

• Gastroenterology
• Neuromodulation
• Bariatric interventions

Background:

• Rising global prevalence of obesity and metabolic disorders linked to autonomic nervous system imbalance.
• Surgically implanted gastric pacemakers demonstrated vagal tone augmentation for satiety and weight control.
• Need for less invasive methods to modulate autonomic nervous system activity.

Purpose of the Study:

• To assess the feasibility of endoscopic implantation of a brain-neuromodulator (BNM) in the proximal gastric wall.
• To evaluate the biocompatibility and biosafety of the novel endoscopic device.
• To measure changes in vagal tone via heart rate variability (HRV) following implantation.

Main Methods:

• Experimental study in pigs using a prototype self-powered BNM.
• Endoscopic submucosal implantation of the device on the lesser gastric curve.
• Radiological, endoscopic, and autopsy evaluations for feasibility, position, and safety.
• Heart rate variability (HRV) assessment to quantify parasympathetic tone changes.

Main Results:

• Successful and uncomplicated endoscopic implantation of the BNM.
• Device remained stable without displacement or significant side effects.
• Post-procedural HRV significantly increased, indicating enhanced vagal tone.
• Autopsy confirmed device integrity and absence of gastric wall damage.

Conclusions:

• Endoscopic submucosal placement of a miniaturized, battery-free BNM is feasible, biocompatible, and safe.
• The device demonstrates potential for increasing parasympathetic tone via vagal nerve stimulation.
• Further validation and parameter optimization are required for future clinical translation in obesity and metabolic disorders.