Clinical trial NCT05810428: Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
Official title: Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Trigeminal Nerve Diseases
Virtual Reality
Artificial Intelligence
Radiosurgery
Magnetic Resonance Imaging
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, randomized controlled trial, assessor blinded. The investigators plan to enroll 50 TN patients with indications to undergo surgical treatment. Fifty TN participants will be randomly allocated into two groups: individuals in the experimental group (GKRS-VR) will undergo GKRS followed by immersive VR-based sensorimotor neuromodulation training, whilst control group (CT) will undergo only GKRS. A group of 50 age- and sex-matched controls will also be recruited.
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Numeric Rating Scale for pain (NRS) changes
timeFrame: Baseline, month 3 and month 12
measure: Barrow Neurological Institute (BNI) pain score changes
timeFrame: Baseline, month 3 and month 12
Secondary outcomes:
measure: McGill Pain Questionnaire (MPQ) changes
timeFrame: Baseline, month 3 and month 12
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, month 3 and month 12
measure: Central Sensitization Inventory (CSI) changes
timeFrame: Baseline, month 3 and month 12
measure: Tampa Scale of Kinesiophobia (TSK) changes
timeFrame: Baseline, month 3 and month 12
measure: Craniofacial Pain and Disability Inventory (CFPDI) changes
timeFrame: Baseline, month 3 and month 12
measure: Penn Facial Pain Scale (PFPS) changes
timeFrame: Baseline, month 3 and month 12
measure: Percentage of displacement of virtual face landmarks
timeFrame: Baseline, month 3 and month 12
measure: 12-item Allodynia Symptom Checklist (ASC-12) scale changes
timeFrame: Baseline, month 3 and month 12
measure: Trigeminal reflexes testing
timeFrame: Baseline, month 3 and month 12
measure: Longitudinal changes of brain gray matter volumes
timeFrame: Baseline, month 3 and month 12
measure: Longitudinal changes of white matter microstructural abnormalities
timeFrame: Baseline, month 3 and month 12
measure: Resting-State Functional Connectivity MRI changes
timeFrame: Baseline, month 3 and month 12
measure: Functional MRI changes
timeFrame: Baseline, month 3 and month 12
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
References:
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