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

Last updated: December 20, 2024
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Dystonia

Treatment

genetic panel

EEG-MEG

fMRI

Clinical Study ID

NCT06716983
DYScover
GR-2021-12375334
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • Patient implanted with a neurostimulator capable of chronically recording LFPs andwhich is fully compatible with magnetic fields up to 3 Tesla.

  • Age>12 years

Exclusion

Exclusion Criteria:

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

  • 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.

Study Design

Total Participants: 15
Treatment Group(s): 4
Primary Treatment: genetic panel
Phase:
Study Start date:
December 28, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Active - Recruiting

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