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| ID | Type | Description | Link |
|---|---|---|---|
| GR-2021-12375334 | Other Grant/Funding Number | Italian Ministry of Health |
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The goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (DBS) influences brain networks. The investigators will enroll patients with dystonia implanted with DBS of the Globus Pallidus internus (GPi) with sensing implantable neurostimulators, capable of measuring GPi local field potentials (LFPs).
The main questions it aims to answer are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI | Diagnostic Test | fMRI in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials | ||
| EEG-MEG | Diagnostic Test | EEG-MEG in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials | ||
| registration of local field potentials | Diagnostic Test | registration of local field potential in patients with dystonia implanted with deep brain stimulation | ||
| genetic panel | Diagnostic Test | genetic panel for dystonia |
| Measure | Description | Time Frame |
|---|---|---|
| Local field potentials | To confirm the prominent pallidal low frequency oscillations in GPi (LFPs in alpha and theta bands) in dystonic patients and to evaluate the modifications in LFPs after DBS in the long term. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Coherence LFPs-MEG | To evaluate coherence and/or correlation between GPi acivity and the neural activity in the basal ganglia-thalamo-cortical circuitry. LFPs signals will be co-registered to both EEG/MEG and resting state fMRI. | 1 year |
| Clinical correlations |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators will enroll 15 consecutive patients with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Levi, M.D. | Contact | 0039.02.2394.2411 | 2411 | vincenzo.levi@istituto-besta.it |
| Nico Golfrè Andreasi, M.D. | Contact | 0039.02.2394.2411 | nic.goan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Levi, MD | Fondazione IRCCS Istituto Neurologico Carlo Besta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29661966 | Background | 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. | |
| 34922163 |
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Blood Samples with DNA
to find a correlation between modulation of pallidal low-frequency activity and patient's clinical improvement. |
| 1 year |
| 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. |
| 34388744 | Background | 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. |
| 27725721 | Background | 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. |
| 34261338 | Background | 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. |
| 31483903 | Background | 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. |
| 28159649 | Background | 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. |
| 30064317 | Background | 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. |
| 25935723 | Background | 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. |
| 33059051 | Background | 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. |
| 29331287 | Background | 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. |
| 25212852 | Background | 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. |
| 34328685 | Background | 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. |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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