Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study (APODOUL)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
apomorphine
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, Pain, Nociceptive threshold, Functional imaging, Cerebral activity, Dopamine agonist.
Eligibility 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.
Sites / Locations
- Service de Neurologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Apomorphine
Placebo
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
NCT ID
NCT00524914
First Posted
September 4, 2007
Last Updated
April 10, 2008
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT00524914
Brief Title
Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study
Acronym
APODOUL
Official Title
Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Pain, Nociceptive threshold, Functional imaging, Cerebral activity, Dopamine agonist.
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Apomorphine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
apomorphine
Intervention Description
Acute apomorphine subcutaneous 3 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo subcutaneous
Primary Outcome Measure Information:
Title
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.
Time Frame
the primary outcome is measured after acute administration of apomorphine ( after 30 minutes )
Secondary Outcome Measure Information:
Title
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.
Time Frame
after acute administration of apomorphine
Title
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.
Time Frame
After administration of apomorphine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL-COURBON, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
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Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study
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