Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT07231302
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stimulation of the Dentate Nucleus of the Cerebellum for the Treatment of Refractory Spasticity With or Without Dystonia
Sponsor:
Kleber Paiva Duarte
Organization:
Study Overview
Official 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)
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DN_DBS
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: