Dopaminergic Loss and Pain in Parkinson's Disease

University Hospital, Toulouse20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Parkinson's Disease Pain

Interventions

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)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992). * Male or Female patients, aged from 30 to 70 years. * Patients must benefit from the French Social security system. * Patients must give a written informed consent. * Female fertile patients must use an efficient method of contraception. If patients suffer from chronic pain, pain must be related to Parkinson's disease. Exclusion Criteria: * Patients with a syndrome other than the idiopathic Parkinson's disease. * Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed. * Patients suffering from another disease causing chronic pain. * Patients suffering from cancer. * Patients with cognitive dysfunction. * Patients not able to complete the scales. * Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception. * Patients not willing to participle in the trial.

Locations (1)

University Hospital Toulouse

Toulouse, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.

Secondary Outcomes

Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale