Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study (MSAJOY)
This study has been completed.
Sponsor:
University Hospital, Toulouse
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01044992
First received: January 6, 2010
Last updated: February 25, 2010
Last verified: February 2010
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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
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:
|
Parkinson Disease Multiple System Atrophy Shy-Drager Syndrome Atrophy Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases |
Cardiovascular Diseases Pathological Conditions, Anatomical Dopamine Dopamine Agents Levodopa Dopamine Agonists Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 18, 2013