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DystoniaDYScoverNCT06716983

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

An observational study of Dystonia, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dystonia
What is being tested?
fMRI, EEG-MEG and registration of local field potentials
How many people
15 participants
Where
1 siteItaly
Study dates
28 Dec 2023to Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vincenzo Levi, M.D. contact

0039.02.2394.2411 ext. 2411

vincenzo.levi@istituto-besta.it

Nico Golfrè Andreasi, M.D. contact

0039.02.2394.2411

nic.goan@gmail.com

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

    Vincenzo Levi, MD, 0039.02.2394.2411, vincenzo.levi@istituto-besta.it

    Nico Golfrè Andreasi, MD, 0039.02.2394.2411, nico.golfreandreasi@istituto-besta.it

    Recruiting

Other trials in Italy

About this study

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

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.
Conditions
Dystonia
Being tested
fMRI, EEG-MEG, registration of local field potentials, genetic panel
Keywords
Dystonia, Movement disorders, Deep Brain Stimulation, DBS, Local Field potentials, biomarker, Magnetoencephalography, MEG, fMRI
Medical subject headings
Dystonia, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRIDiagnostic test

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

  • EEG-MEGDiagnostic test

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

  • registration of local field potentialsDiagnostic test

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

  • genetic panelDiagnostic test

    genetic panel for dystonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (2)

  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.

    Measured: 1 year

  2. Clinical correlations

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start28 Dec 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716983
Sponsor's protocol ID
DYScover
Other IDs
GR-2021-12375334
Acronym
DYScover
Status last verified
Mar 2026
First submitted
2 Dec 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang DD, de Hemptinne C, Miocinovic S, Ostrem JL, Galifianakis NB, San Luciano M, Starr PA. Pallidal Deep-Brain Stimulation Disrupts Pallidal Beta Oscillations and Coherence with Primary Motor Cortex in Parkinson's Disease. J Neurosci. 2018 May 9;38(19):4556-4568. doi: 10.1523/JNEUROSCI.0431-18.2018. Epub 2018 Apr 16.

    PubMed 29661966

  • Udupa K, Bhattacharya A, Chen R. Exploring the connections between basal ganglia and cortex revealed by transcranial magnetic stimulation, evoked potential and deep brain stimulation in dystonia. Eur J Paediatr Neurol. 2022 Jan;36:69-77. doi: 10.1016/j.ejpn.2021.12.004. Epub 2021 Dec 10.

    PubMed 34922163

  • Thenaisie Y, Palmisano C, Canessa A, Keulen BJ, Capetian P, Jimenez MC, Bally JF, Manferlotti E, Beccaria L, Zutt R, Courtine G, Bloch J, van der Gaag NA, Hoffmann CF, Moraud EM, Isaias IU, Contarino MF. Towards adaptive deep brain stimulation: clinical and technical notes on a novel commercial device for chronic brain sensing. J Neural Eng. 2021 Aug 31;18(4). doi: 10.1088/1741-2552/ac1d5b.

    PubMed 34388744

  • Talakoub O, Neagu B, Udupa K, Tsang E, Chen R, Popovic MR, Wong W. Time-course of coherence in the human basal ganglia during voluntary movements. Sci Rep. 2016 Oct 11;6:34930. doi: 10.1038/srep34930.

    PubMed 27725721

  • Sirica D, Hewitt AL, Tarolli CG, Weber MT, Zimmerman C, Santiago A, Wensel A, Mink JW, Lizarraga KJ. Neurophysiological biomarkers to optimize deep brain stimulation in movement disorders. Neurodegener Dis Manag. 2021 Aug;11(4):315-328. doi: 10.2217/nmt-2021-0002. Epub 2021 Jul 15.

    PubMed 34261338

  • Scheller U, Lofredi R, van Wijk BCM, Saryyeva A, Krauss JK, Schneider GH, Kroneberg D, Krause P, Neumann WJ, Kuhn AA. Pallidal low-frequency activity in dystonia after cessation of long-term deep brain stimulation. Mov Disord. 2019 Nov;34(11):1734-1739. doi: 10.1002/mds.27838. Epub 2019 Sep 4.

    PubMed 31483903

  • Prescott IA, Marino RA, Levy R. Field evoked potentials in the globus pallidus of non-human primates. Neurosci Res. 2017 Jul;120:18-27. doi: 10.1016/j.neures.2017.01.007. Epub 2017 Jan 31.

    PubMed 28159649

  • Pina-Fuentes D, Beudel M, Little S, van Zijl J, Elting JW, Oterdoom DLM, van Egmond ME, van Dijk JMC, Tijssen MAJ. Toward adaptive deep brain stimulation for dystonia. Neurosurg Focus. 2018 Aug;45(2):E3. doi: 10.3171/2018.5.FOCUS18155.

    PubMed 30064317

  • Neumann WJ, Jha A, Bock A, Huebl J, Horn A, Schneider GH, Sander TH, Litvak V, Kuhn AA. Cortico-pallidal oscillatory connectivity in patients with dystonia. Brain. 2015 Jul;138(Pt 7):1894-906. doi: 10.1093/brain/awv109. Epub 2015 May 1.

    PubMed 25935723

  • Litvak V, Florin E, Tamas G, Groppa S, Muthuraman M. EEG and MEG primers for tracking DBS network effects. Neuroimage. 2021 Jan 1;224:117447. doi: 10.1016/j.neuroimage.2020.117447. Epub 2020 Oct 12.

    PubMed 33059051

  • Harmsen IE, Rowland NC, Wennberg RA, Lozano AM. Characterizing the effects of deep brain stimulation with magnetoencephalography: A review. Brain Stimul. 2018 May-Jun;11(3):481-491. doi: 10.1016/j.brs.2017.12.016. Epub 2018 Jan 4.

    PubMed 29331287

  • Barow E, Neumann WJ, Brucke C, Huebl J, Horn A, Brown P, Krauss JK, Schneider GH, Kuhn AA. Deep brain stimulation suppresses pallidal low frequency activity in patients with phasic dystonic movements. Brain. 2014 Nov;137(Pt 11):3012-3024. doi: 10.1093/brain/awu258. Epub 2014 Sep 10.

    PubMed 25212852

  • Averna A, Arlotti M, Rosa M, Chabardes S, Seigneuret E, Priori A, Moro E, Meoni S. Pallidal and Cortical Oscillations in Freely Moving Patients With Dystonia. Neuromodulation. 2023 Dec;26(8):1661-1667. doi: 10.1111/ner.13503. Epub 2022 Feb 15.

    PubMed 34328685

Questions about this trial

What is this clinical trial studying?

An observational study of Dystonia, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincenzo Levi, M.D. (0039.02.2394.2411 ext. 2411, vincenzo.levi@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local field potentials (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716983, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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