Under construction – not a live service
Sign in
Enrolling by invitationNo phase

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

Key facts

Who runs it
IRCCS San Raffaele
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Enrolling by invitation
People taking part
50 people, planned
Started
6 Apr 2023
Expected to end
30 Apr 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • GKRS-VR training
  • Control Group
Record updated
27 February 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • metal implants, pacemaker, etc
  • Use of illicit drugs
  • Any significant psychiatric disease
  • Any other condition according to the Investigator would make the subject unsuitable for the study
  • 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
  • Pregnancy or breastfeeding
  • Brain pathology shown by brain MRI and/or neurophysiological examination
  • Any person unable to understand and follow the instructions of the investigators

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • GKRS-VR trainingTreatment being tested

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

  • Control GroupExisting treatment, for comparison

    Control group (CT) will undergo only GKRS

  • Healthy subjectsNo study treatment, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
27 February 2026