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

Recruitingn/aAges 12 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT06716983 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 migh

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • fMRI
  • EEG-MEG
  • registration of local field potentials
  • genetic panel
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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