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

San Donato Group (GSD)

Status: Enrolling

Conditions: Artificial Intelligence; Trigeminal Nerve Diseases; Radiosurgery; Trigeminal Neuralgia; Virtual Reality; Magnetic Resonance Imaging

Treatments: Procedure: Control Group; Procedure: GKRS-VR training

Study type: Interventional

Funder types: Other

Identifiers

NCT05810428

GR-2021-12374601

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

GKRS-VR training

Experimental group

Description:

GKRS-VR group will undergo GKRS and neuromodulation based on Virtual Reality sensorimotor rehabilitation using an immersive system

Treatment:

Procedure: GKRS-VR training

Control Group

Active Comparator group

Description:

Control group (CT) will undergo only GKRS

Treatment:

Procedure: Control Group

Healthy subjects

No Intervention group

Description:

Age- and sex-matched healthy subjects recruited to compare neuropsychological,clinical and structural/functional magnetic resonance imaging characteristics at baseline.