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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07231302

Acronym

DN_DBS

Enrollment

Registered

2025-11-17

Start date

2016-04-01

Completion date

2024-11-30

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Deep brain stimulation, Nucleus dentatus, Dystonia, Ataxia

Brief 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

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.

Interventions

OTHERAnalytical observation

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

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
DSB in the dentate nucleus	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026