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

NCT06716983 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

  • Dystonia

Interventions

DIAGNOSTIC_TEST

fMRI

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

DIAGNOSTIC_TEST

EEG-MEG

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

DIAGNOSTIC_TEST

registration of local field potentials

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

DIAGNOSTIC_TEST

genetic panel

genetic panel for dystonia

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Vincenzo Levi, MD · Fondazione IRCCS Istituto Neurologico Carlo Besta

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716983 on ClinicalTrials.gov