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

NCT ID: NCT07231302

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2024-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Final Stereotactics coordinates in DN-DBS

Computational dataset

Analytical observation

Intervention Type OTHER

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

Interventions

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Analytical observation

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

Intervention Type OTHER

Eligibility Criteria

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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, refractory to drug and physiotherapy treatment;
3. Signed the term of free and informed consent

Exclusion Criteria

1. Age under 18 years;
2. Presence of severe anatomical deformities in the cerebellum and/or brainstem;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kleber Paiva Duarte

OTHER

Sponsor Role lead

Responsible Party

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Kleber Paiva Duarte

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 34513166 (View on PubMed)

Other Identifiers

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32779514.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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