Mechanisms of Fronto-Subcortical Dysfunction: Comparing P... | NCT00790634

Studies
Mechanisms of Fronto-Subcortical Dysfunction: Comparing PD and OCD

NCT00790634

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Nov 13, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Parkinson's Disease
Obsessive-Compulsive Disorder

Interventions

Not provided

Countries

Not provided

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 12, 2008

First Submission Date that Met QC Criteria

Nov 12, 2008

First Posted Date

Nov 13, 2008Estimated

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

Nov 12, 2008

Last Update Posted Date

Nov 13, 2008Estimated

Name	Class
University of Haifa	OTHER
Israel Science Foundation	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 characterize and compare irregularities in dopaminergic function in fronto-subcortical circuits, between Parkinson's Disease patients (ON and OFF medication) and patients with obsessive-compulsive disorder, by examining performance on cognitive tasks involving cognitive flexibility, decision-making, and attentional bias.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's Disease		Patients with idiopathic Parkinson's disease
Obsessive-compulsive disorder		Individuals with a diagnosis of obsessive-compulsive disorder
OCD controls		Healthy controls, matched in age and number to obsessive-compulsive group
PD controls		Healthy controls, matched in age and number to Parkinson's disease group

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

idiopathic PD or
OCD
for control group - age-matched to study groups

Exclusion Criteria:

psychotic symptoms (past or present)
head injury with loss of consciousness
other neurological conditions (excepting PD in PD group)
for OCD group - use of dopaminergic medications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

private and hospital-based clinics, healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sharon Hassin, MD	Contact	97235305791		shassin@post.tau.ac.il
Sari Meril, M.Sc	Contact	972

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D009771	Obsessive-Compulsive Disorder

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