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|---|---|---|---|
| AOL 2007 |
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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.
Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.
The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient.
Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pain disorders | Other | patients with Parkinson's disease presenting pain disorders |
|
| without pain disorders | Other | patients with Parkinson's disease without pain disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ioflupane 123I (DATSCAN®) | Drug | One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
If patients suffer from chronic pain, pain must be related to Parkinson's disease.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Brefel-Courbon, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30706197 | Result | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C519528 | ioflupane |
| C087552 | 2-carbomethoxy-8-(3-fluoropropyl)-3-(4-iodophenyl)tropane |
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|
| 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). |
| Hospital Anxiety and Depression (HAD) scale | Evaluation will be done within three hours before image acquisition (SPECT). |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |