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Deep Brain Stimulation

NBM ON for Memory Loss (2T-DBS Trial)

N/A
Waitlist Available
Led By Alfonso Fasano, MD, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

2T-DBS Trial 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.

Eligible Conditions
  • Memory Loss
  • Parkinson's Disease

2T-DBS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cognition after GPi/NBM DBS
Change in motor function (UPDRS)GPi/NBM DBS
To assess the occurrence of adverse events from GPi/NBM DBS and occurrence of adverse events.
Secondary outcome measures
To assess the impact on health-related quality-of-life and various non-motor symptoms of PD
To use neuroimaging biomarkers (MEG and FDG-PET) to examine localized effects of NBM stimulation

2T-DBS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NBM ONExperimental Treatment1 Intervention
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.
Group II: NBM OFFPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)
2017
N/A
~10

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
689 Previous Clinical Trials
1,018,637 Total Patients Enrolled
Alfonso Fasano, MD, PhDPrincipal InvestigatorUniversity of Toronto
3 Previous Clinical Trials
122 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Archives of NeurologyJournal
Increased Cerebral Metabolism After 1 Year of Deep Brain Stimulation in Alzheimer Disease
Smith, Gwenn S., Adrian W. Laxton, David F. Tang-Wai, Mary Pat McAndrews, Andreea Oliviana Diaconescu, Clifford I. Workman, and Andres M. Lozano. 2012. “Increased Cerebral Metabolism After 1 Year of Deep Brain Stimulation in Alzheimer Disease”. Archives of Neurology. American Medical Association (AMA). doi:10.1001/archneurol.2012.590.
clinicaltrials.govStudy
GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment
Alfonso Fasano 2017. "GPi+NBM DBS in Parkinson's Disease With Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04571112.
~1 spots leftby Apr 2025
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