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

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04268030

Collaborator

(none)

Enrollment

Location

6.6

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: collection of LFPs

Study Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 11, 2020

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

change in beta symmetry [1 day]
LFP

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

undergoing bilateral STN-DBS
diagnosis of Parkinson's disease

Exclusion Criteria:

no Parkinson's disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gian Pal, Assistant Professor, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT04268030

Other Study ID Numbers:

17112804-IRB02

First Posted:

Feb 13, 2020

Last Update Posted:

Jul 9, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jul 9, 2021