Enrolling by invitation NCT05810428
Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GKRS-VR training, Control Group.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia, Trigeminal Nerve Diseases, Virtual Reality, Artificial Intelligence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure GKRS-VR training
One month after radiosurgery, GKRS-VR subjects will receive neuromodulation treatment twice a week (30' per time), for 8 consecutive weeks followed by 9 months of remote rehabilitation. GKRS-VR group will perform neuromodulation based on VR sensorimotor rehabilitation using an immersive system developed ad-hoc. Treatments will include voluntary mimic movements reinforced by VR augmented feedback, consisting in the reflection of a real-time avatar animation, multiplied when needed, associated wit - Procedure Control Group
Control Group will undergo only radiosurgery with no rehabilitation and they will perform only clinical evaluation at study entry, after three months and one year.
Primary outcome measures
- Numeric Rating Scale for pain (NRS) changes [Time frame: Baseline, month 3 and month 12]
- Barrow Neurological Institute (BNI) pain score changes [Time frame: Baseline, month 3 and month 12]
Secondary outcome measures (12)
- McGill Pain Questionnaire (MPQ) changes [Time frame: Baseline, month 3 and month 12]
- Pain Catastrophizing Scale (PCS) [Time frame: Baseline, month 3 and month 12]
- Central Sensitization Inventory (CSI) changes [Time frame: Baseline, month 3 and month 12]
- Tampa Scale of Kinesiophobia (TSK) changes [Time frame: Baseline, month 3 and month 12]
- Craniofacial Pain and Disability Inventory (CFPDI) changes [Time frame: Baseline, month 3 and month 12]
- Penn Facial Pain Scale (PFPS) changes [Time frame: Baseline, month 3 and month 12]
- Percentage of displacement of virtual face landmarks [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]
- Trigeminal reflexes testing [Time frame: Baseline, month 3 and month 12]
- Longitudinal changes of brain gray matter volumes [Time frame: Baseline, month 3 and month 12]
- Longitudinal changes of white matter microstructural abnormalities [Time frame: Baseline, month 3 and month 12]
- Resting-State Functional Connectivity MRI changes [Time frame: Baseline, month 3 and month 12]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS San Raffaele — Milan
Publications
- Barzaghi LR, Pompeo E, Albano L, Del Vecchio A, Mortini P. Gamma Knife radiosurgery for cluster-tic syndrome unresponsive to medical treatment: illustrative case. J Neurosurg Case Lessons. 2021 Jul 26;2(4):CASE2191. doi: 10.3171/CASE2191. eCollection 2021 Jul 26. PMID 35854679
- Barzaghi LR, Albano L, Scudieri C, Gigliotti CR, Nadin F, Del Vecchio A, Mortini P. Gamma Knife Radiosurgery for Trigeminal Neuralgia: Role of Trigeminal Length and Pontotrigeminal Angle on Target Definition and on Clinical Effects. World Neurosurg. 2020 Oct;142:e140-e150. doi: 10.1016/j.wneu.2020.06.147. Epub 2020 Jun 26. PMID 32599193
- Albano L, Agosta F, Basaia S, Castellano A, Messina R, Parisi V, Barzaghi LR, Falini A, Mortini P, Filippi M. Alterations of brain structural MRI are associated with outcome of surgical treatment in trigeminal neuralgia. Eur J Neurol. 2022 Jan;29(1):305-317. doi: 10.1111/ene.15105. Epub 2021 Sep 24. PMID 34519132
- Filippi M, Agosta F, Scola E, Canu E, Magnani G, Marcone A, Valsasina P, Caso F, Copetti M, Comi G, Cappa SF, Falini A. Functional network connectivity in the behavioral variant of frontotemporal dementia. Cortex. 2013 Oct;49(9):2389-401. doi: 10.1016/j.cortex.2012.09.017. Epub 2012 Oct 24. PMID 23164495
- Filippi M, Basaia S, Canu E, Imperiale F, Meani A, Caso F, Magnani G, Falautano M, Comi G, Falini A, Agosta F. Brain network connectivity differs in early-onset neurodegenerative dementia. Neurology. 2017 Oct 24;89(17):1764-1772. doi: 10.1212/WNL.0000000000004577. Epub 2017 Sep 27. PMID 28954876
- Agosta F, Spinelli EG, Marjanovic IV, Stevic Z, Pagani E, Valsasina P, Salak-Djokic B, Jankovic M, Lavrnic D, Kostic VS, Filippi M. Unraveling ALS due to SOD1 mutation through the combination of brain and cervical cord MRI. Neurology. 2018 Feb 20;90(8):e707-e716. doi: 10.1212/WNL.0000000000005002. Epub 2018 Jan 24. PMID 29367447
- Basaia S, Agosta F, Cividini C, Trojsi F, Riva N, Spinelli EG, Moglia C, Femiano C, Castelnovo V, Canu E, Falzone Y, Monsurro MR, Falini A, Chio A, Tedeschi G, Filippi M. Structural and functional brain connectome in motor neuron diseases: A multicenter MRI study. Neurology. 2020 Nov 3;95(18):e2552-e2564. doi: 10.1212/WNL.0000000000010731. Epub 2020 Sep 10. PMID 32913015
- Basaia S, Agosta F, Diez I, Bueicheku E, d'Oleire Uquillas F, Delgado-Alvarado M, Caballero-Gaudes C, Rodriguez-Oroz M, Stojkovic T, Kostic VS, Filippi M, Sepulcre J. Neurogenetic traits outline vulnerability to cortical disruption in Parkinson's disease. Neuroimage Clin. 2022;33:102941. doi: 10.1016/j.nicl.2022.102941. Epub 2022 Jan 19. PMID 35091253
Identifiers
NCT: NCT05810428 · GR-2021-12374601