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Waarom blokkeren sommige Parkinson patiënten tijdens het lopen?

Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23006
Enrollment
80
Registered
2009-11-16
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease with and without Freezing of Gait, healthy controls.

Interventions

1. 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
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 assigne
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.

Sponsors

University Medical Center Groningen University of Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parkinson's disease according to the UK brain bank criteria.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
First 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

MeasureTime frame
First 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.

Contacts

Public ContactJanneke Koerts

Hanzeplein 1

j.koerts@neuro.umcg.nl+31 (0)50 3611009

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)