Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
Enrolling by invitation · Not applicable
Conditions studied: Trigeminal Neuralgia, Trigeminal Nerve Diseases, Virtual Reality, Artificial Intelligence, Radiosurgery, Magnetic Resonance Imaging
In brief
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.
Key facts
- Study ID
- NCT05810428
- Run by
- IRCCS San Raffaele
- People needed
- 50
- Starts
- 2023-04-06
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- IRCCS San Raffaele — Milan, Italy
Full record on ClinicalTrials.gov
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