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

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 site in 1 country15 target enrollmentDecember 28, 2023

ConditionsDystonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dystonia
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Enrollment: 15
Locations: 1
Primary Endpoint: Local field potentials
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 28, 2023

End Date

June 1, 2026

Last Updated

last month

Study Type

Observational

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Local field potentials

Time Frame: 1 year

To 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.