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Clinical Trials in Italy / NCT06716983
Recruiting Observational

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

NCT06716983 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Phase
Observational
Started
2023-12-28
Last updated
2026-03-30

Condition(s) studied

Dystonia

Investigational drug(s) / intervention(s)

fMRIEEG-MEGregistration of local field potentialsgenetic panel

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

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

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

genetic panel: genetic panel for dystonia

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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06716983 on ClinicalTrials.gov ↗ ← All trials in Italy