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Waarom blokkeren sommige Parkinson patiŽnten tijdens het lopen?


- candidate number6721
- NTR NumberNTR2110
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2009
- Secondary IDsNL28119.042.09 CCMO
- Public TitleWaarom blokkeren sommige Parkinson patiŽnten tijdens het lopen?
- Scientific TitleFreezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option.
- ACRONYM
- hypothesisParkinson's disease patients with Freezing of Gait show impairments shifting between response sets and a reduced activation in brain areas involved in shifting between response sets, relative to Parkinson's disease patients without Freezing of Gait.

Methylphenidate improves gait and the ability to shift between response sets and will lead to a relative increase of activation in the brain areas involved in shifting between response sets in Parkinson's disease patients with Freezing of Gait, compared to a placebo.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Freezing of Gait
- Inclusion criteriaParkinson's disease according to the UK brain bank criteria.
- Exclusion criteria1. Presence of neurological central nervous system disorders other that idiopathic PD;
2. Surgical treatment for idiopathic PD, such as deep brain stimulation;
3. Dementia;
4. Other significant co-morbidity;
5. Contraindications to MRI scanning;
6. Contraindications to the use of Methylphenidate.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate31-jan-2013
- Target number of participants80
- Interventions1. Parkinson's disease patients with Freezing of Gait, Parkinson's disease patients without Freezing of Gait and healthy controls will be assessed with a set-shifting task in a behavioral setting and during functional Magnetic Resonance Imaging with simultaneous Electromyography (fMRI-EMG). In addition, gait characteristics will be assessed;
2. Parkinson's disease patients with Freezing of Gait will be treated with Methylphenidate or placebo for three months with a dosage of 1 mg/kg/day. Methylphenidate or placebo will be randomly assigned (50/50);
3. After three months the assessment of gait characteristics and set-shifting in a behavioral setting and during fMRI-EMG will be repeated in Parkinson's disease patients with Freezing of Gait.
- Primary outcomeFirst primary outcome: Performance of Parkinson's disease patients with Freezing of Gait on behavioral tasks compared to Parkinson's disease patients without Frezzing of Gait and healthy controls.

Second primary outcome: Cerebral activation patterns during shifting between response sets in Parkinson's disease patients with Freezing of Gaot, relative to Parkinson's disease patients without Freezing of Gait and healthy controls.

Third primary outcome: Change of performance on response shifting task and gait trajectory after administration of Methylphenidate in Parkinson's disease patients with Freezing of Gait, relative to placebo.

Fourth primary outcome: Cerebral activation change after administration of Methylphenidate in Parkinson's disease patients with Freezing of Gait, relative to placebo.
- Secondary outcomeFirst secondary outcome is the performance on the motor tasks of all groups, compared to the performance on the cognitive task and dual task, by comparing the number of correct responses.

Second secondary outcome is the cerebral activation pattern during shifting between motor task compared to the cerebral activation patterns during shifting between cognitive tasks and during dual tasks in all groups.
- TimepointsPilot study: 6 months;
Data collection: 1.5 years;
Data analysis and publication: 1 year.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Janneke Koerts
- CONTACT for SCIENTIFIC QUERIES Janneke Koerts
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryBackground:
Freezing of gait (FOG) is common in Parkinsonís disease (PD). The underlying mechanism of FOG is however unknown. It was hypothesized that PD patients with FOG are unable to keep different tasks (motor or cognitive) on-line and can not flexibly shift between response sets. Whether shifting impairments underlie the mechanism of motor freezing has never been investigated. Impairments in set-shifting have been associated with a reduced activation in the fronto-striatal circuits in PD. Thus, if impairments in shifting between response sets underlie motor freezing there may be a close inter-relationship between the fronto-striatal circuitry disturbances underlying both shifting impairments and motor freezing.
Treatment options are insufficient to relieve FOG in PD. Recently, Methylphenidate (MPH) has been introduced as a treatment option. No randomized, clinical controlled trial has been performed to investigate the efficacy of MPH for FOG in PD. Furthermore, there is no understanding of the neural mechanism by which MPH ameliorates cognition and gait in PD. Studies suggest that the neural effects of MPH vary according to task requirements. In healthy controls MPH modulated the striatal activity when response shifting was required.

Objectives:
To investigate whether impairments of shifting between response sets underlie motor freezing in PD and to investigate the efficacy and the neural mechanism by which MPH improves gait and cognition in PD patients with FOG.
- Main changes (audit trail)
- RECORD16-nov-2009 - 29-nov-2009


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