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

MI-összefoglaló

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The trial is looking for adults with trigeminal neuralgia (a nerve condition causing face pain) who are due to have Gamma Knife radiosurgery. A separate group of healthy people of similar age and sex is also included for comparison.

Életkor

Over 18 years

Nem

All sexes

A betegség stádiuma

Trigeminal neuralgia diagnosed by ICHD-3 criteria, with a medical reason to have radiosurgery.

A részvétel fő kizáró okai

• Cannot have an MRI scan or cannot lie still in the scanner; metal implants or a pacemaker
• Pregnancy or breastfeeding
• Any significant psychiatric disease or use of illicit drugs
• Brain disease seen on brain MRI or nerve tests
• Unable to understand and follow the study team's instructions

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

• GKRS-VR trainingA vizsgált kezelés

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

• Control GroupMár használt kezelés, összehasonlításként

  Control group (CT) will undergo only GKRS

• Healthy subjectsNincs vizsgálati kezelés, összehasonlításként

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