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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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06716983
Acronym
DYScover
Enrollment
15
Registered
2024-12-04
Start date
2023-12-28
Completion date
2026-06-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia

Keywords

Dystonia, Movement disorders, Deep Brain Stimulation, DBS, Local Field potentials, biomarker, Magnetoencephalography, MEG, fMRI

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.

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Local field potentials1 yearTo confirm the prominent pallidal low frequency oscillations in GPi (LFPs in alpha and theta bands) in dystonic patients and to evaluate the modifications in LFPs after DBS in the long term.

Secondary

MeasureTime frameDescription
Coherence LFPs-MEG1 yearTo evaluate coherence and/or correlation between GPi acivity and the neural activity in the basal ganglia-thalamo-cortical circuitry. LFPs signals will be co-registered to both EEG/MEG and resting state fMRI.
Clinical correlations1 yearto find a correlation between modulation of pallidal low-frequency activity and patient's clinical improvement.

Countries

Italy

Contacts

CONTACTVincenzo Levi, M.D.
vincenzo.levi@istituto-besta.it0039.02.2394.2411
CONTACTNico Golfrè Andreasi, M.D.
nic.goan@gmail.com0039.02.2394.2411
PRINCIPAL_INVESTIGATORVincenzo Levi, MD

Fondazione IRCCS Istituto Neurologico Carlo Besta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026