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NCT Number: NCT02657681

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

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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Key information

Conditions

Dyskinesia, Medication-Induced Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Dyskinesia, Drug-Induced Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neurotoxicity Syndromes Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CINAC, Hospital Universitario Puerta del Sur

Móstoles, Madrid, 28938, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tSMS

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.

Other names: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

SHAM

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).

Other names: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

Primary outcomes

  1. 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.

    Time frame: One day after the end of treatment compared to baseline

Secondary outcomes

  1. 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.

    Time frame: One week after the end of treatment compared to baseline

  2. Dyskinesia severity evaluated for each body segment

    Time frame: Baseline, one day and one week after the end of treatment

  3. Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)

    Time frame: One day and one week after the end of treatment

  4. Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale

    Time frame: Baseline, one day and one week after the end of treatment

Sponsors and collaborators

Lead sponsor

Fundación de investigación HM

Other

Collaborators

  • Hospital Nacional de Parapléjicos de Toledo
  • Hospital San Carlos, Madrid
  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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