Investigating brain network dynamics in dystonia patients with deep brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the relationship between genetic mutations and brain changes in dystonia

  This study is trying to see how genetic changes linked to dystonia affect the brain in people with the condition compared to healthy individuals.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT03428009

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Low-intensity focused ultrasound for movement and seizure disorders

  This trial will try low-intensity focused ultrasound (LIFUS) to see if it can safely change brain activity in people with movement disorders or epilepsy.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07417280

• Measuring brain network activity to predict and improve outcomes in children with dystonia

  This project will test whether noninvasive brain and muscle recordings, and comparing DBS on versus off, can predict and help improve motor outcomes for children with dystonia.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07325175

• Wearable sensors to predict DBS results for people with dystonia

  This study will test whether wearable sensors that record walking patterns before surgery can predict how well deep brain stimulation will work for people with dystonia.

  Recruiting Ruijin Hospital · Shanghai · NCT07323602

• Using GPi brain signals to guide DBS programming for primary dystonia

  This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.

  Recruiting Newcastle-upon-Tyne Hospitals NHS Trust · Newcastle upon Tyne, Tyne & Wear · NCT07309133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.