Dyskinesia, Medication-Induced, Parkinson's Disease
Conditions
Brief summary
This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).
Interventions
DEVICEtSMS
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body.
DEVICEsham
A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain).
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Hospital Nacional de Parapléjicos de Toledo
Hospital San Carlos, Madrid
Fundación de investigación HM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* advanced idiopathic Parkinson's disease (Brain Bank criteria) * optimal clinical response to dopaminergic medication (\>30% UPDRS-III improvement) * presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb
Exclusion criteria
* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) * other main neuropsychiatric co-morbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment. | One day after the end of treatment compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment. | One week after the end of treatment compared to baseline |
| Dyskinesia severity evaluated for each body segment | Baseline, one day and one week after the end of treatment |
| Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC) | One day and one week after the end of treatment |
| Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale | Baseline, one day and one week after the end of treatment |
Countries
Spain
Outcome results
None listed