Multi-targets, Single-lead GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study examines the safety and feasibility of DBS in treating the movement and cognitive dysfunction in Parkinson's 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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• PD-MCI that affects multiple cognitive domains (including memory, visuo-spatial deficits etc.). diagnosis based on a comprehensive neuropsychological assessment (gold-standard) allowing the application of Level II MDS diagnostic criteria (Dubois et al. 2007)

• PD fulfilling standard criteria for bilateral GPi DBS surgery

• Patient's ability to provide informed consent and comply with study protocol.

Locations
Other Locations
Canada
Toronto Western Hospital
Toronto
Time Frame
Start Date: December 4, 2017
Completion Date: March 1, 2021
Participants
Target number of participants: 6
Treatments
Experimental: NBM ON
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.~The NBM ON arm will have constant NBM stimulation for 8 weeks.
Sham Comparator: NBM OFF
The post-surgical double-blind cross-over phase with randomization will follow once programming settings are determined. Under constant GPi DBS, patients will receive NBM DBS active or sham for 8 weeks followed by an 8-week cross-over.~The NBM OFF arm will have NBM stimulation turned off for 8 weeks.
Sponsors
Leads: University of Toronto

This content was sourced from clinicaltrials.gov

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