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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01044992
First received: January 6, 2010
Last updated: February 25, 2010
Last verified: February 2010
  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
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

Resource links provided by NLM:


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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: LLAU ME, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT01044992     History of Changes
Other Study ID Numbers: 01 036 08, PHRC
Study First Received: January 6, 2010
Last Updated: February 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Atrophy
Multiple System Atrophy
Autonomic Nervous System Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Agents
Peripheral Nervous System Agents
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Pathological Conditions, Anatomical
Primary Dysautonomias
Dopamine
Dopamine Agents
Dopamine Agonists
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics

ClinicalTrials.gov processed this record on October 29, 2014