Development of a Face Valid Executive Functioning Task | NCT00918112

Studies
Development of a Face Valid Executive Functioning Task

NCT00918112

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Sep 2009Actual

Completion Date

Nov 2016Actual

First Submitted Date

Jun 8, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2022

Last Update Posted Date

Mar 31, 2022Actual

Name	Class
American Parkinson's Disease Association, Inc	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to develop a task to measure executive thinking skills that can be performed in a laboratory setting, but has clear parallels to the thinking demands of real life situations, and can be administered to patients such as those with Parkinson's who have difficulty moving.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's Disease		Meets criteria for definite Parkinson's Disease
Healthy Controls		- Must be in good health

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Brief Inclusion Criteria Parkinson's Disease (PD) group:

Must have definite PD
have clear benefit from levodopa

Brief Exclusion Criteria PD Group and Control:

Hx of stroke
Head injury
Visual loss

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Recruit participants through Volunteer for Health, word of mouth, and from a clinical population at the Washington University in St Louis School of Medicine's Neurological Clinical Research Unit (NCRU).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tamara G Hershey, PhD.	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

This was a small pilot study and consent was not obtained to share data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided