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Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study (MSAJOY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044992
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : February 26, 2010
Information provided by:
University Hospital, Toulouse

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multisystemic Atrophy Radiation: H215O PET Drug: Levodopa Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : May 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2006

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Difference between motor activation of the three groups in OFF condition
  2. Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • MSA patients will be included if they met Gilman criteria for probable MSA. All those subjects will be distinguished between parkinsonian form (MSA-P) and cerebellar form (MSA-C). All will underwent Unified Parkinson's Disease Rating Scale UPDRS and International Cooperative Ataxia Rating Scale ICARSS. All patients will have a poor response to levodopa (<30% of the UPDRS score).
  • Patients with PD will be included if they suffered from idiopathic PD according to the criteria of UKPDSBB and had a positive response to levodopa (≥ 30% improvement on UPDRS part III).
  • All healthy subjects will have normal neurological examination and none will have a history of neurological, cardiovascular or psychiatric disturbance.
  • For all subjects, handedness will be determined by the Edinburg test. For all patients (MSA and PD) a MRI brain scan will be realized

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044992

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University Hospital
Bordeaux, France, 33
University Hospital
Clermont-Ferrand, France, 63003
University Hospital
Marseille, France, 13000
University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
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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
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Responsible Party: LLAU ME, University Hospital Toulouse Identifier: NCT01044992    
Other Study ID Numbers: 01 036 08
PHRC ( Other Grant/Funding Number: 2001 Regional PHRC )
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010
Keywords provided by University Hospital, Toulouse:
Multi systemic atrophy
Parkinson Disease
PET investigation
Motor control
Comparison with Parkinson disease and dopaminergic challenge.
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs