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CompletedNCT07231302DN_DBSUpdated Nov 17, 2025

Stimulation of the Dentate Nucleus of the Cerebellum for the Treatment of Refractory Spasticity With or Without Dystonia

An observational study in Ataxia - Other, Dystonia Disorder and Tremor, Essential, sponsored by Kleber Paiva Duarte. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Kleber Paiva Duarte · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

Electrical stimulation (DBS) through electrodes implanted in the dentate nucleus of the cerebellum for the treatment of tremor intractable with medication, dystonia due to cerebrovascular disease (stroke), sequelae of traumatic brain injury, and ataxia (a disease that causes incoordination of movements). Use of advanced magnetic resonance imaging techniques and recording of nerve cell activity in this nucleus

Read the detailed description

To establish anatomical and functional criteria, based on stereotactic imaging and electrophysiological recordings, that enable the precise implantation of electrodes in the DN and its efferent projections for the treatment of movement disorders. This study aims to describe a surgical technique for the implantation of deep brain electrodes targeting the stimulation (DBS) of the dentate nucleus (DN) and its efferent projections, supported by the magnetic resonance imaging (MRI), the diffusion tensor imaging (DTI), reformatted in the stereotomographic images and related to stereotactic landmarks and checked with semimicro deep brain recording.

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Conditions studied

  • Ataxia - Other
  • Dystonia Disorder
  • Tremor, Essential
  • Choreatic Disorder
  • Deep Brain Stimulation Surgery

Keywords

  • Deep brain stimulation
  • Nucleus dentatus
  • Dystonia
  • Ataxia
03

In context

Dystonic Disorders

95 studies on the registry are indexed under Dystonic Disorders; 19 are open to participants now.

This study's enrollment of 20 is below the median of 56 across 50 observational studies indexed under Dystonic Disorders.

Browse Dystonic Disorders studies →

Lead sponsor

This is the only study on the registry with Kleber Paiva Duarte as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with dystonia, ataxia or tremor

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 or older
  2. Clinical diagnosis of cerebellar syndrome resulting from stroke and spinocerebellar degeneration, intractable tremor, primary or secondary dystonia, to drug and physiotherapy treatment;
  3. Signed the term of free and

Exclusion criteria

Exclusion Criteria:

  1. Age under 18 years;
  2. Presence of severe anatomical deformities in the cerebellum and/or brainstem;
Terms in these criteria, in plain language(2)

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Final Stereotactics coordinates in DN-DBS

    Computational dataset

    Other: Analytical observation

Interventions

  • OtherAnalytical observation

    Analysts observation; CT + MRI + DTI pre and post operative stereotactic coordinates - implants DBS in DN

06

What researchers measure

Primary outcomes

  1. DSB in the dentate nucleus

    All stereotactic image calculations the definitive location of the implants in relation to the targets proposed in the ND, were reanalyzed in a digital environment that included co-registration of the preoperative MRI, DTI, and stereotomograph

    Time frame: From enrollment to the end of treatment at 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Diniz JM, Cury RG, Iglesio RF, Lepski GA, Franca CC, Barbosa ER, de Andrade DC, Teixeira MJ, Duarte KP. Dentate nucleus deep brain stimulation: Technical note of a novel methodology assisted by tractography. Surg Neurol Int. 2021 Aug 9;12:400. doi: 10.25259/SNI_338_2021. eCollection 2021. PubMed 34513166 ↗

Individual participant data

Plan to share: Undecided — There are other projects similar to this one underway. I'd like to be able to connect with other researchers and share our challenges and findings.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2016 to primary completion in Nov 2023, 91 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2025
First posted
Nov 17, 2025
StartActual
Apr 1, 2016
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2024
Last update
Nov 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07231302
Lead sponsor
Kleber Paiva Duarte
Responsible party
Kleber Paiva Duarte (assistant professor, University of Sao Paulo) — Sponsor-investigator
First posted
Nov 17, 2025
Start date
Apr 1, 2016
Primary completion
Nov 30, 2023
Completion
Nov 30, 2024
Last update
Nov 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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