Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study (MSAJOY)
Background: Multiple System Atrophy (MSA) is an atypical parkinsonian syndrome including cerebellar impairment and poor response to dopatherapy. The objective of the study is to assess right-hand motor activation in MSA patients before and after an acute levodopa challenge and to compare these data with those obtained in patients with Parkinson Disease (PD) and healthy volunteers (HV).
Methods: Eighteen MSA patients, eight PD patients and 10 age-matched HV will be included. rCBF measurements with H215O PET will be performed at rest and during a right hand movement. Statistical parametric mapping will be used to analyze motor versus rest in OFF and ON condition and effect of levodopa on motor activation.
Hypothesis: MSA and PD patient should recruited different motor networks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge|
- The "movement effect" consists of comparing the images obtained during hand movement with those acquired at rest for each group (MSA, PD and Healthy subjects) using the Family Wise Error (FWE) statistical threshold in OFF and ON conditions [ Designated as safety issue: Yes ]
- Difference between motor activation of the three groups in OFF condition [ Designated as safety issue: No ]
- Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Experimental: Drug and radiation
Levodopa and H215O PET
Radiation: H215O PET
H215O PET investigations will be performed during two pharmacological conditions: OFF (e.g after 12 hours of usual dopaminergic treatment discontinuation) and ON (after an acute oral levodopa challenge) in all subjects. During each PET there will be two motor conditions: rest (no movement, hand and wrist lying on the joystick) and a right-hand movement, consisting of moving joystick in 4 four different directions avoiding sequence repetition performed at rest and during a right hand movement.
Other Name: To measure rCBF, 300 MBq of H215O will be administered for each 80-second emission scan.Drug: Levodopa
Levodopa: the dosage of levodopa challenge will be equivalent to the first morning dose increased by 100 mg of levodopa whereas the dosage will be 200 mg in healthy subjects.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044992
|Bordeaux, France, 33|
|Clermont-Ferrand, France, 63003|
|Marseille, France, 13000|
|Toulouse, France, 31059|
|Study Director:||Olivier Rascol, MD PHD||University Hospital, Toulouse|
|Study Director:||Pierre Payoux, MD PhD||University Hospital, Toulouse|
|Principal Investigator:||Olivier Rascol, MD PhD||University Hospital, Toulouse|
|Principal Investigator:||Franck Durif, MD PhD||University Hospital, Clermont-Ferrand|
|Principal Investigator:||Jean-Philippe Azulay, MD PhD||University Hospital, Marseille|
|Principal Investigator:||François Tison, MD PhD||University Hospital, Bordeaux|