Clinical Trials Directory

Trials / Completed

CompletedNCT07231302

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
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Kleber Paiva Duarte · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2016-04-01
Primary completion
2023-11-30
Completion
2024-11-30
First posted
2025-11-17
Last updated
2025-11-17

Source: ClinicalTrials.gov record NCT07231302. Inclusion in this directory is not an endorsement.