RecruitingNCT06716983

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

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


Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Enrollment

15 participants

Start Date

Dec 28, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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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Interventions

DIAGNOSTIC_TESTfMRI

fMRI in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials

DIAGNOSTIC_TESTEEG-MEG

EEG-MEG in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials

DIAGNOSTIC_TESTregistration of local field potentials

registration of local field potential in patients with dystonia implanted with deep brain stimulation

DIAGNOSTIC_TESTgenetic panel

genetic panel for dystonia


Locations(1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

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NCT06716983


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