Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects
NCT ID: NCT05810428
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-04-06
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GKRS-VR training
GKRS-VR group will undergo GKRS and neuromodulation based on Virtual Reality sensorimotor rehabilitation using an immersive system
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 with different targets to reach based on specific facial gestures. The execution of motion multiplier on avatar will be allowed in order to personalize treatments, emphasizing a graded exposure to pain perception. In addition, the investigators will develop a dedicated mobile-application for remote rehabilitation with the aim of prescribing VR augmented feedback home exercises and immersive VR pain neuromodulation.
Control Group
Control group (CT) will undergo only GKRS
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.
Healthy subjects
Age- and sex-matched healthy subjects recruited to compare neuropsychological,clinical and structural/functional magnetic resonance imaging characteristics at baseline.
No interventions assigned to this group
Interventions
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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 with different targets to reach based on specific facial gestures. The execution of motion multiplier on avatar will be allowed in order to personalize treatments, emphasizing a graded exposure to pain perception. In addition, the investigators will develop a dedicated mobile-application for remote rehabilitation with the aim of prescribing VR augmented feedback home exercises and immersive VR pain neuromodulation.
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.
Eligibility Criteria
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Inclusion Criteria
* age \>18 years;
* indication to undergo radiosurgical treatment;
* willingness and ability to comply with scheduled visits and other trial procedures.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Prof. Massimo Filippi
Prof.
Locations
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IRCCS San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Basaia S, Agosta F, Wagner L, Canu E, Magnani G, Santangelo R, Filippi M; Alzheimer's Disease Neuroimaging Initiative. Automated classification of Alzheimer's disease and mild cognitive impairment using a single MRI and deep neural networks. Neuroimage Clin. 2019;21:101645. doi: 10.1016/j.nicl.2018.101645. Epub 2018 Dec 18.
Alemanno F, Houdayer E, Emedoli D, Locatelli M, Mortini P, Mandelli C, Raggi A, Iannaccone S. Efficacy of virtual reality to reduce chronic low back pain: Proof-of-concept of a non-pharmacological approach on pain, quality of life, neuropsychological and functional outcome. PLoS One. 2019 May 23;14(5):e0216858. doi: 10.1371/journal.pone.0216858. eCollection 2019.
Emedoli D, Arosio M, Tettamanti A, Iannaccone S. Virtual Reality Augmented Feedback Rehabilitation Associated to Action Observation Therapy in Buccofacial Apraxia: Case Report. Clin Med Insights Case Rep. 2021 Feb 15;14:1179547621994579. doi: 10.1177/1179547621994579. eCollection 2021.
Other Identifiers
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GR-2021-12374601
Identifier Type: -
Identifier Source: org_study_id
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