Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study
Information source: University Hospital, Toulouse
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: apomorphine (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Hospital, Toulouse Official(s) and/or principal investigator(s):
Christine BREFEL-COURBON, PhD, Principal Investigator, Affiliation: University Hospital, Toulouse
Summary
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations.
We suppose that painful symptoms could be related to the neurotransmitter deficit of PD. So,
we would like to evaluate the involvement of dopaminergic system in nociceptive processing in
PD patients. The objectives of this study is to assess and to compare the effect of a
dopamine agonist administration on the nociceptive threshold and on the cerebral activity
using positrons emission tomography (PET scan) in two groups of PD patients (in 16 painful PD
patients and in 16 pain free PD patients). We hypothesise that dopamine agonist could
normalise nociceptive threshold and cerebral activity which were both abnormal in PD
patients. Moreover, we think that painful PD patients could be more improved by dopamine
agonist than pain free PD patients.
Clinical Details
Official title: Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.
Study design: Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: The primary outcome of this study is subjective nociceptive threshold using thermotest. We determinate thermal nociceptive threshold using a Peltier- based contact temperature stimulation device with a contact thermode.
Secondary outcome: Objective nociceptive threshold using the nociceptive flexion reflex (RIII) which can be elicited by a nociceptive electrical stimulation to the sural nerve and recorded in the ipsilateral Biceps Femoris muscle.Cerebral activity using H215O PET analysis of regional Cerebral Blood Flow (rCBF) on subjects while they received alternate randomized noxious (defined as pain threshold) and innocuous stimuli.
Detailed description:
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations.
Painful complaints with various description (muscle cramps, painful dystonia, aching,
numbness, tingling, burning, vibrating, lancinating) are described and can or cannot be
related to motor symptoms. Physiopathology of pain in PD is discussed. It has been suggested
that the occurrence of painful symptoms could be in part due to central modification of
nociception and basal ganglia damage and the dopaminergic deficit would be expected to
eliminate the inhibitory influence on thalamic nociceptive activity. Recently, data have
shown that PD patient had a lower nociceptive threshold than healthy volunteers. Our team has
reported that levodopa administration normalised this nociceptive threshold and decreased
cerebral activity measured with positrons emission tomography (PET- H215O during experimental
nociceptive stimulation) in several nociceptive cortical areas which were overactive in PD.
These findings suggest that central dopamine system plays an important part in the control of
the nociceptive pathways in PD. Nevertheless, in the central nervous system, levodopa could
be converted in dopamine but also in noradrenaline modulating noradrenergic system. In order
to confirm the involvement of dopaminergic system in nociceptive processing in PD, we would
like to assess a specific drug of dopamine system (a dopamine agonist, apomorphine) in PD
patients.
The primary objective of this study is to assess the effect of dopamine agonist acute
administration versus placebo on the nociceptive subjective threshold in two groups of PD
patients (painful PD patients, n =16 and pain free PD patients, n = 16). This is a controlled
cross over, double blind, randomised study.
The secondary objectives are to assess and to compare the apomorphine effect on the objective
nociceptive threshold (nociceptive flexion reflex) and on the activation of cerebral areas
using functional imaging (TEP- H215O) during experimental nociceptive stimulation in the two
groups of PD patients.
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients suffering from Parkinson's disease
- PD patients with a Hoehn et Yahr < à 3 (Hoehn et Yahr 1967)
- PD patients treated by dopaminergic drugs (levodopa, dopamine agonist, IMAO-B,
ICOMT…)
- Painful PD patients : PD patients suffering from chronic pain (> 3 months) which is
related to PD and suggests neuropathic pain
- Pain free PD patients : PD patients without any pain related to PD.
Exclusion Criteria:
- Patients with chronic disease resulting in chronic pain (severe arthosis….)
- PD patients with a Hoehn et Yahr stage > 3 (Hoehn et Yahr 1967)
- Patients with cancer
- Patients who underwent a PET scan in the last three months
- Pregnancy
- Patients with a contra indication of use of apomorphine or domperidone.
Locations and Contacts
Service de Neurologie, Toulouse 31059, France
Additional Information
Starting date: September 2007
Ending date: March 2008
Last updated: April 10, 2008
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