Investigating brain network dynamics in dystonia patients with deep brain stimulation
Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical (CBGTC) Network Dynamics in Dystonic Patients With Deep Brain Stimulation (DBS)
This study looks at how deep brain stimulation affects brain activity in people with dystonia to see if it helps improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06716983 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the pathophysiology of dystonia and the effects of deep brain stimulation (DBS) on brain networks. It will enroll patients with dystonia who have undergone DBS surgery and are equipped with neurostimulators that can measure local field potentials (LFPs). The study will assess how DBS influences LFPs over time and whether changes in these signals correlate with clinical improvements. Participants will undergo various evaluations, including magnetoencephalography (MEG) and functional MRI (fMRI), to gather comprehensive data on brain activity.
Who should consider this trial
Good fit: Ideal candidates are patients aged over 12 diagnosed with idiopathic or genetic dystonia who have undergone DBS surgery.
Not a fit: Patients with acquired conditions causing dystonia or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of dystonia and improve treatment strategies using deep brain stimulation.
How similar studies have performed: While similar studies have explored DBS effects, this specific multimodal approach to understanding dystonia's pathophysiology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Vincenzo Levi, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: Vincenzo Levi, M.D.
- Email: vincenzo.levi@istituto-besta.it
- Phone: 0039.02.2394.2411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.