NCT06716983

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2023Jun 2026

Study Start

First participant enrolled

December 28, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

December 2, 2024

Last Update Submit

March 25, 2026

Conditions

Dystonia

Keywords

DystoniaMovement disordersDeep Brain StimulationDBSLocal Field potentialsbiomarkerMagnetoencephalographyMEGfMRI

Outcome Measures

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.

    1 year

Secondary Outcomes (2)

  • Coherence LFPs-MEG

    1 year

  • Clinical correlations

    1 year

Interventions

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

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnancy, and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

RECRUITING

Related Publications (13)

  • 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.

    PMID: 29661966BACKGROUND

  • 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.

    PMID: 34922163BACKGROUND

  • 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.

    PMID: 34388744BACKGROUND

  • 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.

    PMID: 27725721BACKGROUND

  • 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.

    PMID: 34261338BACKGROUND

  • 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.

    PMID: 31483903BACKGROUND

  • 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.

    PMID: 28159649BACKGROUND

  • 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.

    PMID: 30064317BACKGROUND

  • 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.

    PMID: 25935723BACKGROUND

  • 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.

    PMID: 33059051BACKGROUND

  • 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.

    PMID: 29331287BACKGROUND

  • 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.

    PMID: 25212852BACKGROUND

  • 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.

    PMID: 34328685BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples with DNA

MeSH Terms

Conditions

DystoniaMovement Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vincenzo Levi, MD

    Fondazione IRCCS Istituto Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Levi, M.D.

CONTACT

0039.02.2394.2411vincenzo.levi@istituto-besta.it

Nico Golfrè Andreasi, M.D.

CONTACT

0039.02.2394.2411nic.goan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 4, 2024

Study Start

December 28, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

IT(1)