Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients With Deep Brain Stimulation

Официальное название

Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical (CBGTC) Network Dynamics in Dystonic Patients With Deep Brain Stimulation (DBS)

Обзор

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: * 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.

Вмешательства

• Диагностический тест fMRI
  fMRI in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
• Диагностический тест EEG-MEG
  EEG-MEG in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
• Диагностический тест registration of local field potentials
  registration of local field potential in patients with dystonia implanted with deep brain stimulation
• Диагностический тест genetic panel
  genetic panel for dystonia

Первичные конечные точки

• Local field potentials [Срок оценки: 1 year]

Вторичные конечные точки (2)

• Coherence LFPs-MEG [Срок оценки: 1 year]
• Clinical correlations [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients diagnosed with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus
• 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

Критерии исключения

• Evidence of CNS pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology,
• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan

Публикации

• 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. PMID 29661966
• 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. PMID 34922163
• 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. PMID 34388744
• 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. PMID 27725721
• 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. PMID 34261338
• 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. PMID 31483903
• 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. PMID 28159649
• 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. PMID 30064317

Идентификаторы

NCT: NCT06716983 · DYScover · GR-2021-12375334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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