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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-30

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).

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Detailed Description

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Conditions

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Dyskinesia, Medication-Induced Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tSMS

30 min of tSMS, one session per day, for 9 days over 2 weeks

Group Type EXPERIMENTAL

tSMS

Intervention Type DEVICE

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.

sham

30 min of sham, one session per day, for 9 days over 2 weeks

Group Type PLACEBO_COMPARATOR

sham

Intervention Type DEVICE

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).

Interventions

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tSMS

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.

Intervention Type DEVICE

sham

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).

Intervention Type DEVICE

Other Intervention Names

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MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain) MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

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