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

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Trial details

Who runs it
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Trial code
NCT06716983
Record updated
30 March 2026
Original description
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).Read full original descriptionShow less

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

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06716983