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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Dyskinesia, Medication-Induced
• Intervention / Treatment: Device: tSMS; Device: sham

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain, 28938
      • CINAC, Hospital Universitario Puerta del Sur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fundación de investigación HM
• Collaborators: Michael J. Fox Foundation for Parkinson's Research; Hospital San Carlos, Madrid; Hospital Nacional de Parapléjicos de Toledo
• Investigators: Principal Investigator: Guglielmo Foffani, PhD, CINAC, Hospital Universitario HM Puerta del Sur

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Neurotoxicity Syndromes; Parkinson Disease; Dyskinesias; Dyskinesia, Drug-Induced
• Other Study ID Numbers: MJFOX-9205; 9205 (Other Grant/Funding Number: Michael J. Fox Foundation)