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

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

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Key information

Conditions

Ataxia - Other Ataxia Central Nervous System Diseases Chorea Choreatic Disorder Deep Brain Stimulation Surgery Dyskinesias Dystonia Dystonia Disorder Dystonic Disorders Essential Tremor Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tremor, Essential

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Age under 18 years;
Presence of severe anatomical deformities in the cerebellum and/or brainstem;

Treatment and study plan

Analytical observation

Other

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

Primary outcomes

DSB in the dentate nucleus

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

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

Sponsors and collaborators

Lead sponsor

Kleber Paiva Duarte

Other

Registry information

Official study title

Determination of Stereotactic Landmarks Based on Computer-generated Images and Electrophysiological Recording Patterns for Electrode Implantation for Stimulation of the Dentate Nucleus and Its Fiber Projections Aiming the Treatment of Movement Disorders, Like Secondary Dystonia, Ataxia, Tremor (Essential and Symptomatic)

Acronym: DN_DBS

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2024
First posted: Nov 17, 2025
Registry last updated: Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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