NCT00940914|CompletedPhase 2
Dopaminergic Loss and Pain in Parkinson's Disease
Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain
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Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain
Sponsor study identifier
Secondary identifiers
interventional
20
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
July 2010
Actual (reported)About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2009
Actual (reported)July 17, 2009
Actual (reported)March 2010
Actual (reported)July 2010
Actual (reported)Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters.
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds.
Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale
Evaluation will be done within three hours before image acquisition (SPECT).
Short French version of McGill pain questionnaire (MPQ).
Evaluation will be done within three hours before image acquisition (SPECT).
Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain).
Evaluation will be done within three hours before image acquisition (SPECT).
DN4 scale
Evaluation will be done within three hours before image acquisition (SPECT).
Brief Inventory Pain
Evaluation will be done within three hours before image acquisition (SPECT).
patients with Parkinson's disease presenting pain disorders
patients with Parkinson's disease without pain disorders
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Toulouse
Toulouse, 31059, France
Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.
Christine Brefel-Courbon, MD
University Hospital, Toulouse
20 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2009
First Posted
July 17, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
July 29, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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