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

Launched by IRCCS SAN RAFFAELE · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people suffering from trigeminal neuralgia (TN), a condition that causes severe facial pain. The study will compare two groups of patients: one group will receive a treatment called Gamma Knife radiosurgery (GKRS) alone, while the other group will receive GKRS along with training in virtual reality (VR), which may help reduce their pain perception. Researchers also plan to use MRI scans and artificial intelligence to look for specific brain changes that might predict how well someone will respond to treatment. This information could help doctors personalize pain management for patients with TN.

To participate in this trial, individuals must be at least 18 years old, have a diagnosis of TN, and need radiosurgical treatment. They should also be willing to attend all appointments and follow the study guidelines. However, some people may not qualify, such as those with certain medical devices like pacemakers, those who are pregnant or breastfeeding, or anyone with significant psychiatric conditions. If you join the study, you can expect to undergo the treatment and assessments while contributing to research that may significantly improve how TN is managed in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of TN according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria;
• • age \>18 years;
• • indication to undergo radiosurgical treatment;
• • willingness and ability to comply with scheduled visits and other trial procedures.
• Exclusion Criteria:
• • Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;
• • metal implants, pacemaker, etc.;
• • Pregnancy or breastfeeding;
• • Any significant psychiatric disease;
• • Use of illicit drugs;
• • Brain pathology shown by brain MRI and/or neurophysiological examination;
• • Any person unable to understand and follow the instructions of the investigators;
• • Any other condition according to the Investigator would make the subject unsuitable for the study.