Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 6, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

April 30, 2026

Conditions
Trigeminal NeuralgiaTrigeminal Nerve DiseasesVirtual RealityArtificial IntelligenceRadiosurgeryMagnetic Resonance Imaging
Interventions
PROCEDURE

GKRS-VR training

One month after radiosurgery, GKRS-VR subjects will receive neuromodulation treatment twice a week (30' per time), for 8 consecutive weeks followed by 9 months of remote rehabilitation. GKRS-VR group will perform neuromodulation based on VR sensorimotor rehabilitation using an immersive system developed ad-hoc. Treatments will include voluntary mimic movements reinforced by VR augmented feedback, consisting in the reflection of a real-time avatar animation, multiplied when needed, associated with different targets to reach based on specific facial gestures. The execution of motion multiplier on avatar will be allowed in order to personalize treatments, emphasizing a graded exposure to pain perception. In addition, the investigators will develop a dedicated mobile-application for remote rehabilitation with the aim of prescribing VR augmented feedback home exercises and immersive VR pain neuromodulation.

PROCEDURE

Control Group

Control Group will undergo only radiosurgery with no rehabilitation and they will perform only clinical evaluation at study entry, after three months and one year.

Trial Locations (1)

20132

RECRUITING

IRCCS San Raffaele, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER