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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04268030
Other study ID # 17112804-IRB02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2020
Est. completion date August 30, 2020

Study information

Verified date July 2021
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date August 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria: - undergoing bilateral STN-DBS - diagnosis of Parkinson's disease Exclusion Criteria: - no Parkinson's disease

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in beta symmetry LFP 1 day
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