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

ConditionDystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The investigators will enroll 15 consecutive patients with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Local field potentials

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.

Time frame
1 year

Secondary outcomes

1

Coherence LFPs-MEG

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.

Time frame
1 year
2

Clinical correlations

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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