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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT05810428
• Date of registration: 29/03/2023
• Prospective Registration: Yes
• Primary sponsor: IRCCS San Raffaele
• Public title: Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
• Scientific title: Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
• Date of first enrolment: April 6, 2023
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05810428
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Massimo Filippi, MD

• Name: Massimo Filippi, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Trigeminal Neuralgia

Virtual Reality

Artificial Intelligence

Radiosurgery

Magnetic Resonance Imaging

Trigeminal Nerve Diseases

Intervention(s)

Procedure: Control Group

Procedure: GKRS-VR training

Primary Outcome(s)

Barrow Neurological Institute (BNI) pain score changes [Time Frame: Baseline, month 3 and month 12]

Numeric Rating Scale for pain (NRS) changes [Time Frame: Baseline, month 3 and month 12]

Secondary Outcome(s)

Longitudinal changes of white matter microstructural abnormalities [Time Frame: Baseline, month 3 and month 12]

Tampa Scale of Kinesiophobia (TSK) changes [Time Frame: Baseline, month 3 and month 12]

Pain Catastrophizing Scale (PCS) [Time Frame: Baseline, month 3 and month 12]

Penn Facial Pain Scale (PFPS) changes [Time Frame: Baseline, month 3 and month 12]

Central Sensitization Inventory (CSI) changes [Time Frame: Baseline, month 3 and month 12]

Craniofacial Pain and Disability Inventory (CFPDI) changes [Time Frame: Baseline, month 3 and month 12]

12-item Allodynia Symptom Checklist (ASC-12) scale changes [Time Frame: Baseline, month 3 and month 12]

Functional MRI changes [Time Frame: Baseline, month 3 and month 12]

Longitudinal changes of brain gray matter volumes [Time Frame: Baseline, month 3 and month 12]

Trigeminal reflexes testing [Time Frame: Baseline, month 3 and month 12]

Percentage of displacement of virtual face landmarks [Time Frame: Baseline, month 3 and month 12]

Resting-State Functional Connectivity MRI changes [Time Frame: Baseline, month 3 and month 12]

McGill Pain Questionnaire (MPQ) changes [Time Frame: Baseline, month 3 and month 12]

Secondary ID(s)

GR-2021-12374601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors