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

Not Applicable

Recruiting

• Conditions: Trigeminal Nerve Diseases; Magnetic Resonance Imaging; Artificial Intelligence; Radiosurgery; Trigeminal Neuralgia; Virtual Reality
• Interventions: Procedure: Control Group; Procedure: GKRS-VR training

• Registration Number: NCT05810428
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-29
• Study Start: 2023-04-06
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2025-11-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	Control group (CT) will undergo only GKRS
GKRS-VR training	GKRS-VR training	GKRS-VR group will undergo GKRS and neuromodulation based on Virtual Reality sensorimotor rehabilitation using an immersive system

Primary Outcome Measures

Name	Time	Method
Barrow Neurological Institute (BNI) pain score changes	Baseline, month 3 and month 12	Changes in time in the Barrow Neurological Institute (BNI) pain intensity scale to assess the level of pain in patients with trigeminal neuralgia. BNI values I-III were considered to indicate good outcomes whereas BNI values IV and V indicate poor response to treatment.
Numeric Rating Scale for pain (NRS) changes	Baseline, month 3 and month 12	Changes in time in the Numeric rating scale (NRS): a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire (MPQ) changes	Baseline, month 3 and month 12	The McGill Pain Questionnaire (MPQ) can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. The users are presented with a list of 78 words in 20 sections that are related to pain.The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain, namely, Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Penn Facial Pain Scale (PFPS) changes	Baseline, month 3 and month 12	The Penn Facial Pain Scale (Penn-FPS) was originally developed in order to fully assess the impact of trigeminal neuralgia pain on patients' health-related quality of life. It is a 7-item scale, with a total range of 0 to 10.
Longitudinal changes of brain gray matter volumes	Baseline, month 3 and month 12	3D T1-weighted sequence wil be used to evaluate cortical thickness and subcortical volume changes
Resting-State Functional Connectivity MRI changes	Baseline, month 3 and month 12	Longitudinal changes will be evaluated on functional MRI sequences
12-item Allodynia Symptom Checklist (ASC-12) scale changes	Baseline, month 3 and month 12	presence of allodynia and hypoesthesia; It is a 12-item scale, with a total range of 0 to 12.
Longitudinal changes of white matter microstructural abnormalities	Baseline, month 3 and month 12	White matter damage will be evaluated on diffusion-tensor MRI sequence
Pain Catastrophizing Scale (PCS)	Baseline, month 3 and month 12	The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Craniofacial Pain and Disability Inventory (CFPDI) changes	Baseline, month 3 and month 12	Craniofacial Pain and Disability Inventory (CF-PDI) can be used in research and clinical practice for the assessment of patients with craniofacial pain. It is a 21-item measure and patients give their answers using a 4-point Likert scale scoring from 1 (no problem) to 4 (maximum problem). The scale presents two factors, named Pain and disability (14 items) and Jaw functional status (7 items). The scores of the responses are added with higher scores indicating greater problems
Percentage of displacement of virtual face landmarks	Baseline, month 3 and month 12	Percentage of displacement of virtual face landmarks
Functional MRI changes	Baseline, month 3 and month 12	Functional MRI will be acquired on a 3T scanner during the performance of a task, in which participants will be asked to observe facial gestures during activities of daily living or specific movements different for each subject depending on which action triggers the facial pain.
Central Sensitization Inventory (CSI) changes	Baseline, month 3 and month 12	The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation.The CSI consists of two parts: Part A includes 25 questions related to common central sensitivity syndromes symptoms.Part B determines if the patient has been diagnosed with certain central sensitivity syndromes disorders or related disorders, such as anxiety and depression.
Tampa Scale of Kinesiophobia (TSK) changes	Baseline, month 3 and month 12	The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Trigeminal reflexes testing	Baseline, month 3 and month 12	A series of reflex responses after electrical stimulation of the ophthalmic division (R1 and R2) and maxillary/mandibular division (SP1 and SP2) of the trigeminal nerve

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy