Parkinson's DiseaseNCT00790634
Mechanisms of Fronto-Subcortical Dysfunction: Comparing PD and OCD
An observational study of Parkinson's Disease and Obsessive-Compulsive Disorder, run by Sheba Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Obsessive-Compulsive Disorder
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: private and hospital-based clinics, healthy volunteers
Who may be able to join
- idiopathic PD or
- OCD
- for control group - age-matched to study groups
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Sari Meril, M.Sc contact
About this study
Official title: Characterizing Mechanisms of Fronto-Subcortical Dysfunction: A Comparison Between Parkinson's Disease and Obsessive-Compulsive Disorder
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.
- Conditions
- Parkinson's Disease, Obsessive-Compulsive Disorder
- Medical subject headings
- Parkinson Disease, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- University of Haifa, Israel Science Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790634
- Sponsor's protocol ID
- SHEBA-08-5473-SH-CTIL
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Mechanisms of Fronto-Subcortical Dysfunction: A Comparison Between Parkinson's Disease and Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00790634
- Acronym / sponsor ID
- SHEBA-08-5473-SH-CTIL
- Conditions
- Parkinson's Disease, Obsessive-Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- University of Haifa, Israel Science Foundation
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- private and hospital-based clinics, healthy volunteers
Key inclusion criteria (3 listed)
- idiopathic PD or
- OCD
- for control group - age-matched to study groups
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sari Meril, M.Sc contact
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Obsessive-Compulsive Disorder, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Hassin, MD (97235305791, shassin@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2008.