A Dual-Mode Multifunctional Pulsed Radio-Frequency Stimulator for Trigeminal Neuralgia Relief and its Animal Model

Area of Science:

• Biomedical Engineering
• Neuroscience
• Medical Devices

Background:

• Trigeminal neuralgia (TN) is a debilitating condition causing severe facial pain.
• Current treatments for TN have limitations and side effects.
• Pulsed radio-frequency (PRF) stimulation is an emerging therapy for pain management.

Purpose of the Study:

• To develop and evaluate a miniaturized, programmable implantable stimulator for on-demand TN relief.
• To compare the efficacy of PRF stimulation with conventional medication for TN.
• To assess the safety and neural effects of PRF stimulation on the trigeminal ganglion (TG).

Main Methods:

• Design and fabrication of a micro-system integrating wireless communication, sensor interface, PRF generation, and a logic controller using 0.35 μm CMOS technology.
• Development of an external handheld device for wireless parameter transmission and a medical implanted communication system (MICS) for feedback.
• In vivo animal studies comparing PRF stimulation with standard TN medication, including neural recording and pathological examination.

Main Results:

• The implantable PRF stimulator, measuring 3.1 × 2.7 mm², successfully delivered programmable stimulation waveforms.
• PRF stimulation showed significantly greater effectiveness in TN relief compared to medication, with sustained pain relief for at least 14 days.
• Neural recordings indicated attenuated neuron activity in the TG without severe damage, and pathology confirmed no lesions in the stimulated area.

Conclusions:

• The developed programmable PRF stimulator offers a promising on-demand therapeutic solution for trigeminal neuralgia.
• PRF stimulation presents a more effective and potentially safer alternative to current medications for TN.
• This technology holds potential for improved pain management in patients suffering from trigeminal neuralgia.