Stimulus-response and Parkinson's Disease (SRlearning) | NCT02515136

Studies
Stimulus-response and Parkinson's Disease (SRlearning)

NCT02515136

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Dec 23, 2019Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

Stimulus-response

Countries

France

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Jul 30, 2015

First Submission Date that Met QC Criteria

Jul 31, 2015

First Posted Date

Aug 4, 2015Estimated

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

Dec 20, 2019

Last Update Posted Date

Dec 23, 2019Actual

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

In a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. They will respond to each image by acting on the keyboard in a specific manner. Each participant will repeat that task 384 times per session. A break will be inserted every 12 tests so that participants can rest.

The experiment consists of three sessions. Each image will be presented three times. For the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. In the third presentation, the same task and the same action will be maintained or will be swapped. In this way, It can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's disease	Experimental	Parkinson's disease patients	Behavioral: Stimulus-response
Controls	Other	Healthy volunteers paired with Parkinson's disease patients on sex and age group, whose data will be extracted from a CNRS existing database	Behavioral: Stimulus-response

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulus-response	Behavioral	See summary	Controls Parkinson's disease

Measure	Description	Time Frame
Reaction time (second)		immediate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient : Parkinson's disease Controls: healthy volunteers paired to patients on sex and age group

Exclusion Criteria:

Other neurological condition
Known pregnancy or breastfeeding woman
No medical insurance coverage
Person under legal protection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique A. de Rothschild		Paris		75019	France

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