Clinical trial NCT06716983: Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients with Deep Brain Stimulation
Official title: Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical (CBGTC) Network Dynamics in Dystonic Patients with Deep Brain Stimulation (DBS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dystonia
Keywords: Dystonia
Movement disorders
Deep Brain Stimulation
DBS
Local Field potentials
biomarker
Magnetoencephalography
MEG
fMRI
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will enroll 15 consecutive patients with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.

Brief 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 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 outcomes:
measure: Local field potentials
timeFrame: 1 year
Secondary outcomes:
measure: Coherence LFPs-MEG
timeFrame: 1 year
measure: Clinical correlations
timeFrame: 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Vincenzo Levi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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