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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01044992

First Posted: January 8, 2010

Last Update Posted: February 26, 2010

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Information provided by:

University Hospital, Toulouse

Purpose

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	Intervention
Multisystemic Atrophy	Radiation: H215O PET Drug: Levodopa


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease multiple system atrophy

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

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:

Difference between motor activation of the three groups in OFF condition
Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation


Enrollment:	38
Study Start Date:	May 2002
Study Completion Date:	May 2006
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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Eligibility

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

Criteria

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01044992

Locations


France
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

Investigators


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

More Information


Responsible Party:	LLAU ME, University Hospital Toulouse
ClinicalTrials.gov Identifier:	NCT01044992 History of Changes
Other Study ID Numbers:	01 036 08 PHRC ( Other Grant/Funding Number: 2001 Regional PHRC )
First Submitted:	January 6, 2010
First Posted:	January 8, 2010
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	levodopa MSA Comparison with Parkinson disease and dopaminergic challenge.

Additional relevant MeSH terms:


Parkinson Disease Atrophy Multiple System Atrophy 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 Levodopa	Dopamine Dopamine Agents Dopamine Agonists Antiparkinson Agents Anti-Dyskinesia Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiotonic Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Protective Agents

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