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

Phase

N/A

Condition

Trigeminal Neuralgia

Pain (Pediatric)

Headaches

Treatment

GKRS-VR training

Control Group

Clinical Study ID

NCT05810428

GR-2021-12374601

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

Trigeminal neuralgia (TN) is the most common cause of facial pain. Medical treatment is the first therapeutic choice whereas surgery, including Gamma Knife radiosurgery (GKRS), is indicated in case of pharmacological therapy failure. However, about 20% of subjects lack adequate pain relief after surgery. Virtual reality (VR) technology has been explored as a novel tool for reducing pain perception and might be the breakthrough in treatment-resistant cases. The investigators will conduct a prospective randomized comparative study to detect the effectiveness of GKRS aided by VR-training vs GKRS alone in TN patients. In addition, using MRI and artificial intelligence (AI), the investigators will identify pre-treatment abnormalities of central nervous system circuits associated with pain to predict response to treatment. The investigators expect that brain-based biomarkers, with clinical features, will provide key information in the personalization of treatment options and bring a huge impact in the management and understanding of pain in TN.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Any person unable to lie still within the environment of the MRI scanner for therequired period to perform the study and those where MRI scanning iscontraindicated;
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 unsuitablefor the study.

Study Design