Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients with Deep Brain Stimulation
NCT ID: NCT06716983
Last Updated: 2024-12-27
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
15 participants
OBSERVATIONAL
2023-12-28
2026-06-30
Brief Summary
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The main questions it aims to answer are:
* does DBS influence pallidal LFPs in the long term?
* how the basal-ganglia-thalamo-cortical circuit is modified after DBS?
* do LFPs changes correlate with clinical improvement? Participants will undergo to serial clinical evaluations, magnetoencephalography (MEG) and functional Magnetic Resonance Imaging (fMRI) studies. Primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. These features might be secondarily used in future to provide a framework for an effective application of closed-loop DBS in Dystonia.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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fMRI
fMRI in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
EEG-MEG
EEG-MEG in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
registration of local field potentials
registration of local field potential in patients with dystonia implanted with deep brain stimulation
genetic panel
genetic panel for dystonia
Eligibility Criteria
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Inclusion Criteria
* Patient implanted with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.
* Age\>12 years
Exclusion Criteria
* Focal distribution of dystonia
* Contraindications to brain MRI or EEG/MEG
* Adult subjects unable to express consent to inclusion in the study
* Pregnancy, and breastfeeding.
12 Years
ALL
No
Sponsors
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
Responsible Party
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Principal Investigators
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Vincenzo Levi, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Locations
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Vincenzo Levi, MD
Role: primary
Nico Golfrè Andreasi, MD
Role: backup
Vincenzo Levi, MD
Role: backup
References
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Wang DD, de Hemptinne C, Miocinovic S, Ostrem JL, Galifianakis NB, San Luciano M, Starr PA. Pallidal Deep-Brain Stimulation Disrupts Pallidal Beta Oscillations and Coherence with Primary Motor Cortex in Parkinson's Disease. J Neurosci. 2018 May 9;38(19):4556-4568. doi: 10.1523/JNEUROSCI.0431-18.2018. Epub 2018 Apr 16.
Udupa K, Bhattacharya A, Chen R. Exploring the connections between basal ganglia and cortex revealed by transcranial magnetic stimulation, evoked potential and deep brain stimulation in dystonia. Eur J Paediatr Neurol. 2022 Jan;36:69-77. doi: 10.1016/j.ejpn.2021.12.004. Epub 2021 Dec 10.
Thenaisie Y, Palmisano C, Canessa A, Keulen BJ, Capetian P, Jimenez MC, Bally JF, Manferlotti E, Beccaria L, Zutt R, Courtine G, Bloch J, van der Gaag NA, Hoffmann CF, Moraud EM, Isaias IU, Contarino MF. Towards adaptive deep brain stimulation: clinical and technical notes on a novel commercial device for chronic brain sensing. J Neural Eng. 2021 Aug 31;18(4). doi: 10.1088/1741-2552/ac1d5b.
Talakoub O, Neagu B, Udupa K, Tsang E, Chen R, Popovic MR, Wong W. Time-course of coherence in the human basal ganglia during voluntary movements. Sci Rep. 2016 Oct 11;6:34930. doi: 10.1038/srep34930.
Sirica D, Hewitt AL, Tarolli CG, Weber MT, Zimmerman C, Santiago A, Wensel A, Mink JW, Lizarraga KJ. Neurophysiological biomarkers to optimize deep brain stimulation in movement disorders. Neurodegener Dis Manag. 2021 Aug;11(4):315-328. doi: 10.2217/nmt-2021-0002. Epub 2021 Jul 15.
Scheller U, Lofredi R, van Wijk BCM, Saryyeva A, Krauss JK, Schneider GH, Kroneberg D, Krause P, Neumann WJ, Kuhn AA. Pallidal low-frequency activity in dystonia after cessation of long-term deep brain stimulation. Mov Disord. 2019 Nov;34(11):1734-1739. doi: 10.1002/mds.27838. Epub 2019 Sep 4.
Prescott IA, Marino RA, Levy R. Field evoked potentials in the globus pallidus of non-human primates. Neurosci Res. 2017 Jul;120:18-27. doi: 10.1016/j.neures.2017.01.007. Epub 2017 Jan 31.
Pina-Fuentes D, Beudel M, Little S, van Zijl J, Elting JW, Oterdoom DLM, van Egmond ME, van Dijk JMC, Tijssen MAJ. Toward adaptive deep brain stimulation for dystonia. Neurosurg Focus. 2018 Aug;45(2):E3. doi: 10.3171/2018.5.FOCUS18155.
Neumann WJ, Jha A, Bock A, Huebl J, Horn A, Schneider GH, Sander TH, Litvak V, Kuhn AA. Cortico-pallidal oscillatory connectivity in patients with dystonia. Brain. 2015 Jul;138(Pt 7):1894-906. doi: 10.1093/brain/awv109. Epub 2015 May 1.
Litvak V, Florin E, Tamas G, Groppa S, Muthuraman M. EEG and MEG primers for tracking DBS network effects. Neuroimage. 2021 Jan 1;224:117447. doi: 10.1016/j.neuroimage.2020.117447. Epub 2020 Oct 12.
Harmsen IE, Rowland NC, Wennberg RA, Lozano AM. Characterizing the effects of deep brain stimulation with magnetoencephalography: A review. Brain Stimul. 2018 May-Jun;11(3):481-491. doi: 10.1016/j.brs.2017.12.016. Epub 2018 Jan 4.
Barow E, Neumann WJ, Brucke C, Huebl J, Horn A, Brown P, Krauss JK, Schneider GH, Kuhn AA. Deep brain stimulation suppresses pallidal low frequency activity in patients with phasic dystonic movements. Brain. 2014 Nov;137(Pt 11):3012-3024. doi: 10.1093/brain/awu258. Epub 2014 Sep 10.
Averna A, Arlotti M, Rosa M, Chabardes S, Seigneuret E, Priori A, Moro E, Meoni S. Pallidal and Cortical Oscillations in Freely Moving Patients With Dystonia. Neuromodulation. 2023 Dec;26(8):1661-1667. doi: 10.1111/ner.13503. Epub 2022 Feb 15.
Other Identifiers
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GR-2021-12375334
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DYScover
Identifier Type: -
Identifier Source: org_study_id