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

NCT01044992 | Completed

• 2 other identifiers: 01 036 08PHRC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

Multisystemic Atrophy

Keywords

Multi systemic atrophy; Parkinson Disease; PET investigation; Motor control; levodopa; MSA; Comparison with Parkinson disease and dopaminergic challenge.

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Study Arms (1)

Drug and radiation

EXPERIMENTAL

Levodopa and H215O PET

Radiation: H215O PET; Drug: Levodopa

Interventions

H215O PET RADIATION

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.

Also known as: To measure rCBF, 300 MBq of H215O will be administered for each 80-second emission scan.

Drug and radiation

Levodopa DRUG

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.

Drug and radiation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

University Hospital

Bordeaux, 33, France

Location

University Hospital

Clermont-Ferrand, 63003, France

Location

University Hospital

Marseille, 13000, France

Location

University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Olivier Rascol, MD PHD

  University Hospital, Toulouse

  STUDY DIRECTOR

• Pierre Payoux, MD PhD

  University Hospital, Toulouse

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: May 1, 2002
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2006
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

FR (4)