Clinical Trial: Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge
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.
Detailed Summary:
Subjects. In this prospective study, 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 PET activation study 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. Movement will be paced by an auditory stimulus at a frequency of 0.33 Hz. Each patient will be trained to perform the joystick movement before the PET. During PET investigation, angular wrist speed and angular wrist acceleration will be recorded using a computer recording connected to a joystick. The movement will start 30 seconds before image acquisition. Rest and Movement scan conditions will be replicated, making a total number of 6 six scans per patient in OFF condition and 6 six scans per patient in ON condition. The order of OFF and ON sessions and motor conditions will be fully
Sponsor: University Hospital, Toulouse
Current Primary Outcome: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: University Hospital, Toulouse
Dates:
Date Received: January 6, 2010
Date Started: May 2002
Date Completion:
Last Updated: February 25, 2010
Last Verified: February 2010
