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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Contact Information
Primary
Vincenzo Levi, M.D.
vincenzo.levi@istituto-besta.it
0039.02.2394.2411
Backup
Nico Golfrè Andreasi, M.D.
nic.goan@gmail.com
0039.02.2394.2411
Time Frame
Start Date: 2023-12-28
Estimated Completion Date: 2026-06
Participants
Target number of participants: 15
Sponsors
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov