Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04571112
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2019-09-12
Brief Title:
GPiNBM DBS in Parkinsons Disease With Mild Cognitive Impairment
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Multi-targets Single-lead GPiNBM DBS in Parkinsons Disease With Mild Cognitive Impairment
Status:
COMPLETED
Status Verified Date:
2022-11
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:
2T-DBS
Brief Summary:
This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinsons disease PD Globus pallidus interna GPi stimulation is an established treatment for the motor symptoms in PD but it does not treat the cognitive symptoms that can also be seen in this condition It is theorized that we can improve cognitive dysfunction by stimulating a part of the brain called the nucleus basalis of Meynert NBM which releases a chemical acetylcholine and plays a role in memory and attention By using a novel DBS system Vercise device with 2 electrodes that are designed to stimulate the GPi and NBM we can potentially target the motor and cognitive symptoms of PD with a single intervention
Detailed Description:
Neuronal loss within the cholinergic nucleus basalis of Meynert NBM correlates with cognitive decline in dementing disorders such as Alzheimers disease and Parkinsons disease PD Deep Brain Stimulation targeting the Globus Pallidus interna GPi is an established treatment for the motor symptoms in Parkinsons Disease and stimulating the NBM is believed to stimulate cognitive function Targeting these two regions was previously impossible because they require different frequency stimulations but recent developments in DBS technology allow for the dual stimulation of these nuclei at different frequencies
This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms
This phase-II double-blind cross-over pilot trial will investigate the motor and cognitive effects as well as the presence of adverse effects of combined NBM and GPi DBS The main goal of this pilot trial is to demonstrate the feasibility and safety of the multi-targeting approach in 6 patients with PDD and disabling motor symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None