Stimulation of the Dentate Nucleus of the Cerebellum for the Treatment of Refractory Spasticity With or Without Dystonia
DN_DBS
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)
1 other identifier
observational
20
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedFirst Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedNovember 17, 2025
November 1, 2025
7.7 years
November 13, 2025
November 13, 2025
Conditions
Keywords
Outcome Measures
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
From enrollment to the end of treatment at 16 weeks
Study Arms (1)
Final Stereotactics coordinates in DN-DBS
Computational dataset
Interventions
Analysts observation; CT + MRI + DTI pre and post operative stereotactic coordinates - implants DBS in DN
Eligibility Criteria
Patients with dystonia, ataxia or tremor
You may qualify if:
- 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
You may not qualify if:
- Age under 18 years;
- Presence of severe anatomical deformities in the cerebellum and/or brainstem;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 34513166RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start
April 1, 2016
Primary Completion
November 30, 2023
Study Completion
November 30, 2024
Last Updated
November 17, 2025
Record last verified: 2025-11