Trials / Recruiting
RecruitingNCT06716983
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (estimated)
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-28
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2024-12-04
- Last updated
- 2026-03-30
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06716983. Inclusion in this directory is not an endorsement.