An observational study in Dystonia, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Recruiting at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Observational
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:
213 studies on the registry are indexed under Dystonia; 54 are open to participants now.
This study's planned enrollment of 15 is below the median of 78 across 90 observational studies indexed under Dystonia.
Browse Dystonia studies →Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 84 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
fMRI in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
EEG-MEG in patients with dystonia implanted with deep brain stimulation with neurostimulators capable of recording local field potentials
registration of local field potential in patients with dystonia implanted with deep brain stimulation
genetic panel for dystonia
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
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
Clinical correlations
to find a correlation between modulation of pallidal low-frequency activity and patient's clinical improvement.
Time frame: 1 year
Started Dec 2023 (actual). Primary completion is estimated for Jun 2026, 30 months after the start.
Of 27 observational studies under Dystonia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 58 and three quarters within 188. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta