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NCT Number: NCT06716983

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

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.

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Key information

Conditions

Dystonia Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fMRI

Diagnostic Test

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

EEG-MEG

Diagnostic Test

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

registration of local field potentials

Diagnostic Test

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

genetic panel

Diagnostic Test

genetic panel for dystonia

Primary outcomes

  1. Local field potentials

    Time frame: 1 year

    To confirm the prominent pallidal low frequency oscillations in GPi (LFPs in alpha and theta bands) in dystonic patients and to evaluate the modifications in LFPs after DBS in the long term.

Secondary outcomes

  1. Coherence LFPs-MEG

    Time frame: 1 year

    To evaluate coherence and/or correlation between GPi acivity and the neural activity in the basal ganglia-thalamo-cortical circuitry. LFPs signals will be co-registered to both EEG/MEG and resting state fMRI.

  2. Clinical correlations

    Time frame: 1 year

    to find a correlation between modulation of pallidal low-frequency activity and patient's clinical improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Nico Golfrè Andreasi, M.D.

CONTACT

[email protected]

0039.02.2394.2411

Vincenzo Levi, M.D.

CONTACT

[email protected]

0039.02.2394.2411 ext. 2411

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: DYScover

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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