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The Study of the Impact of Disclosing Imaging Study Information to Trial Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354003
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Institute for Neurodegenerative Disorders

Brief Summary:
The overall goal of the study is to evaluate how research participants in Parkinson Disease studies that include brain imaging with a dopamine transporter ligand choose to receive the imaging data and what is the impact of the imaging data information on the management of their symptoms.

Condition or disease Intervention/treatment
Parkinsonian Syndrome Parkinson Behavioral: A series of questionnaires

Detailed Description:
Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials
Study Start Date : July 2006
Actual Primary Completion Date : June 27, 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: A series of questionnaires
    Research participants who previously underwent ß-CIT imaging will be contacted by the staff at IND to enquire whether they would like to receive their ß-CIT scan data. After signing a Research Participant Information and Consent Form, all research participants will be asked to complete a questionnaire prior to receipt of their imaging data. Those research participants requesting imaging data will be sent their data by IND and may review their data with IND (by phone) and/ or with their study investigator. All research participants will be asked to respond to a second questionnaire after receiving their imaging data and to a third study questionnaire approximately six weeks following receipt of their imaging data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Research participants who previously underwent ß-CIT imaging
Criteria

Inclusion Criteria:

  • Previous participation in imaging study as described within the protocol

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354003


Locations
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United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
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Principal Investigator: Kenneth Marek, MD Institute for Neurodegenerative Disorders
Publications:
Whone, A., et al., The REAL-PET study: Slower progression in early Parkinson's disease treated with ropinirole compared with L-Dopa. Neurology, 2002. 58 (suppl3): p. A82-A83.
Parkinson Study Group, Levodopa and the progression of Parkinson disease. NEMJ, 2004. 351: p. 18-28.
Marek, K., J. Seibyl, and Parkinson Study Group, ß-CIT Scans without evidence of dopaminergic deficit (SWEDD) in the ELLDOPA-CIT and CALM-CIT study: long-term imaging assessment. Neurology, 2003. 60 (Suppl 1): p. A298.

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Responsible Party: Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00354003    
Other Study ID Numbers: IMAG-DIS 01
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Keywords provided by Institute for Neurodegenerative Disorders:
Parkinson
Imaging
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders