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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Contact Information
Primary
Massimo Filippi, MD
filippi.massimo@hsr.it
00390226433054
Backup
Silvia Basaia, PhD
basaia.silvia@hsr.it
00390226433051
Time Frame
Start Date: 2023-04-06
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 50
Treatments
Experimental: GKRS-VR training
GKRS-VR group will undergo GKRS and neuromodulation based on Virtual Reality sensorimotor rehabilitation using an immersive system
Active_comparator: Control Group
Control group (CT) will undergo only GKRS
No_intervention: Healthy subjects
Age- and sex-matched healthy subjects recruited to compare neuropsychological,clinical and structural/functional magnetic resonance imaging characteristics at baseline.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov