NCT00354003

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

Impact of Disclosure of Dopamine Transporter Imaging Studies in PD Clinical Trials

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parkinsonian Syndrome
• Parkinson

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-06-27
• Completion: 2008-08-01
• First posted: 2006-07-19
• Last updated: 2019-04-03

Locations

1 site across 1 country: United States