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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Numeric Rating Scale for pain (NRS) changes [Срок оценки: Baseline, month 3 and month 12]
• Barrow Neurological Institute (BNI) pain score changes [Срок оценки: Baseline, month 3 and month 12]

Вторичные конечные точки (12)

• McGill Pain Questionnaire (MPQ) changes [Срок оценки: Baseline, month 3 and month 12]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline, month 3 and month 12]
• Central Sensitization Inventory (CSI) changes [Срок оценки: Baseline, month 3 and month 12]
• Tampa Scale of Kinesiophobia (TSK) changes [Срок оценки: Baseline, month 3 and month 12]
• Craniofacial Pain and Disability Inventory (CFPDI) changes [Срок оценки: Baseline, month 3 and month 12]
• Penn Facial Pain Scale (PFPS) changes [Срок оценки: Baseline, month 3 and month 12]
• Percentage of displacement of virtual face landmarks [Срок оценки: Baseline, month 3 and month 12]
• 12-item Allodynia Symptom Checklist (ASC-12) scale changes [Срок оценки: Baseline, month 3 and month 12]
• Trigeminal reflexes testing [Срок оценки: Baseline, month 3 and month 12]
• Longitudinal changes of brain gray matter volumes [Срок оценки: Baseline, month 3 and month 12]
• Longitudinal changes of white matter microstructural abnormalities [Срок оценки: Baseline, month 3 and month 12]
• Resting-State Functional Connectivity MRI changes [Срок оценки: Baseline, month 3 and month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS San Raffaele — Milan

Публикации

• 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
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• 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

Идентификаторы

NCT: NCT05810428 · GR-2021-12374601

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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