High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement

The aim is to study a specific group of PD patients, carriers of mutations in the glucocerebrosidase (GBA) gene, which is the most common genetic risk factor for PD and is a harbinger of aggressive cognitive and motor decline. Approximately 12-17% of PD patients undergoing DBS are GBA mutation carriers. GBA mutation carriers with PD have a specific phenotype characterized by more significant motor dysfunction and reduced short-term visual memory function compared with their non-GBA counterparts. Thus as GBA mutation carriers have a "signature" phenotype, the investigators hypothesize that these GBA mutation carriers have a unique "signature" of oscillatory activity that can be distinguished from non-mutation carriers during motor activation and during cognitive tasks. Identification of this "signature" will provide critical information that is required to: 1) understand the underlying neurophysiological mechanisms responsible for the aggressive disease course of GBA associated PD, and 2) further develop customized adaptive DBS systems.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: collection of LFPs

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease (PD) with and without mutations in the GBA gene who already have an implanted deep brain stimulator (DBS) device or those patients with PD-GBA mutation carrier who will be undergoing placement of a DBS device using standard technique with sedation and local anesthesia.

Description

Inclusion Criteria:

• undergoing bilateral STN-DBS
• diagnosis of Parkinson's disease

Exclusion Criteria:

• no Parkinson's disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GBA mutation carriers with PD undergoing STN-DBS	Other: collection of LFPs; collection of local field potentials (LFPs) at rest and during hand opening and closing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in beta symmetry	LFP	1 day

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2020
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 17112804-IRB02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No