Parkinson's disease, in particular the symptom Freezing of Gait
Conditions
Interventions
Trade Name: Ritalin
Product Name: Not applicable
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298599
Current Sponsor code: RV
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parkinson's disease according to the criteria of the UK brain bank criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Presence of neurological central nervous system disorders other than idiopathic Parkinson's disease - Surgical treatment for idiopathic Parkinson's disease, such as deep brain stimulation - Dementia (i.e. a score below the cut-off of the Mattis Dementia Rating Scale) - Other significant co-morbidity - Contraindications to MRI scanning: * metal objects in or near the body, such as a pacemaker, insuline pump, prothesis and/or metal splinters in eye. * tattoos and/or piercings * claustrophobia - Controindications to the use of methylphenidate: * cardiovascular disease, including moderate to severe hypertension * structural cardiac abnormalities * cardiomyopathy * advanced arteriosclerosis * hyperexcitability * renal impairment * porphyria * bipolar disorder * unstable personality * anxiety disorder * history of suicide attempts * gilles de la tourette syndrome * thyriod disease * glaucoma * pregnancy * use of MAO-inhibitors * use of vasopressors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether impairments of shifting between response sets underlie motor freezing in PD an to investigate the efficacy and the neural mechanism by which methylphenidate improves gait and cognition in Parkinson's disease patients with Freezing of Gait.;Secondary Objective: Not applicable.;Primary end point(s): First primary outcome: performance of Parkinson's disease patients with Freezing of Gait on behavioral tasks compared to Parkinson's disease patients without Freezing of Gait. Second primary outcome: cerebral activation patterns during shifting between response sets in Parkinson's disease patients with Freezing of Gait relative to Parkinson's disease patients without Freezing of Gait. Third primary outcome: change of performance on response set shifting task after administration of methylphenidate in PD patients with Freezing of Gait. Fourth primary outcome: cerebral activation change after administration of methylphenidate in PD patients with Freezing of Gait. | — |
Countries
Netherlands
Outcome results
None listed