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

NCT04268030 | Completed

• 1 other identifier: 17112804-IRB02
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• change in beta symmetry

  LFP

  1 day

Study Arms (1)

GBA mutation carriers with PD undergoing STN-DBS

Other: collection of LFPs

Interventions

collection of LFPs OTHER

collection of local field potentials (LFPs) at rest and during hand opening and closing

GBA mutation carriers with PD undergoing STN-DBS

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• no Parkinson's disease

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 11, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)