Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study (MSAJOY)
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| ClinicalTrials.gov Identifier: NCT01044992 |
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Recruitment Status :
Completed
First Posted : January 8, 2010
Last Update Posted : February 26, 2010
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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 |
Show Detailed Description
| 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 |
|---|---|
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Experimental: Drug and radiation
Levodopa and H215O PET
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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. |
- 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
- 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
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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
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
| France | |
| University Hospital | |
| Bordeaux, France, 33 | |
| University Hospital | |
| Clermont-Ferrand, France, 63003 | |
| University Hospital | |
| Marseille, France, 13000 | |
| University Hospital | |
| Toulouse, France, 31059 | |
| 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 |
| 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 Posted: | January 8, 2010 Key Record Dates |
| Last Update Posted: | February 26, 2010 |
| Last Verified: | February 2010 |
Keywords provided by University Hospital, Toulouse:
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Multi systemic atrophy Parkinson Disease PET investigation Motor control |
levodopa MSA Comparison with Parkinson disease and dopaminergic challenge. |
Additional relevant MeSH terms:
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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 |