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Multisystemic AtrophyMSAJOYNCT01044992

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

A study testing H215O PET and Levodopa in people with Multisystemic Atrophy, run by University Hospital, Toulouse at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Multisystemic Atrophy
What is being tested?
H215O PET and Levodopa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
4 sitesFrance
Study dates
May 2002to May 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • University Hospital

    Bordeaux, 33

  • University Hospital

    Clermont-Ferrand, 63003

  • University Hospital

    Marseille, 13000

  • University Hospital

    Toulouse, 31059

Other trials in France

About this study

Official title: Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge

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.

Read the detailed description

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 counterbalanced across subjects to eliminate time and order effects.

H215O will be intravenously injected in the arm contralateral to the hand movement. PET measurements will be performed with an EXACT HR+ tomograph (CTI/Siemens, Knoxville, TN, USA) allowing the simultaneous 3D acquisition of 63 transaxial slices. Spatial resolution after reconstruction reached 4.5 and 4.1 mm in the transaxial and axial direction, respectively {Bendriem, 1996 #39}(19). To measure rCBF, 300 MBq of H215O will be administered for each 80-second emission scan. To allow complete decay of injected tracer activity, image acquisitions will be performed 10 minutes apart.

Image analysis will be performed on a personal computer station (DELL inc, Round Rock, Texas, USA) using the "statistical parametric mapping" package (SPM2, Wellcome Department of Cognitive Neurology, London, United Kingdom). Images of each subject will be realigned to the first volume and normalized to the MNI standard proportional stereotaxic space, which is based on that of Talairach and Tournoux (1988). The images will be coregistered on a template and spatially smoothed with a Gaussian kernel of 12 mm full width at half maximum (FWHM) to take into account variations in gyral anatomy and individual variability in structure-function relationships, and to improve the signal-to-noise ratio.

Statistical analysis :

All baseline characteristics in MSA, PD and healthy volunteers will be compared by the Man-Whitney U test. For PET imaging, the 36 subjects will be included in the same statistical analysis on a voxel-by-voxel basis. Statistical parametric maps will be generated using an ANCOVA model implemented through the General Linear Model formulation of SPM after normalization for global effect by proportional scaling. We will analyze three main effects 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 at P < 0.05 for peak height in OFF and ON conditions. 2) Difference between motor activation of the three groups in OFF condition. 3) Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation. For inter groups comparisons statistical threshold will set at p<0.01 with clusters>10 voxels.

Being tested
H215O PET, Levodopa
Keywords
Multi systemic atrophy, Parkinson Disease, PET investigation, Motor control, levodopa, MSA, Comparison with Parkinson disease and dopaminergic challenge.
Medical subject headings
Multiple System Atrophy, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H215O PETRadiation

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

    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.

  • LevodopaDrug

    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.

Study groups in NCT01044992
Study groupRoleWhat they receive
Drug and radiationExperimentalLevodopa and H215O PET
Receives: Radiation: H215O PET; Drug: Levodopa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)
  1. Difference between motor activation of the three groups in OFF condition

  2. Difference between motor activation during OFF and ON condition in each group reflecting levodopa effect on motor activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2010 (estimated)
  2. Study startMay 2002
  3. Primary completionMay 2005
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01044992
Sponsor's protocol ID
01 036 08
Other IDs
PHRC
Acronym
MSAJOY
Status last verified
Feb 2010
First submitted
6 Jan 2010
Last updated
26 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing H215O PET and Levodopa in people with Multisystemic Atrophy, run by University Hospital, Toulouse at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.

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