Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)

Study Overview
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Brief Summary
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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).

Official Title
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Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)

Conditions
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Dyskinesia, Medication-Induced, Parkinson's Disease

Intervention / Treatment
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* Device: tSMS
* Device: sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tSMS<br>30 min of tSMS, one session per day, for 9 days over 2 weeks | Device: tSMS<br>* 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.<br>* Other names: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain);|
| Placebo Comparator: sham<br>30 min of sham, one session per day, for 9 days over 2 weeks | Device: sham<br>* 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).<br>* Other names: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |