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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657681
• Other study ID #: MJFOX-9205
• Secondary ID: 9205
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Fundación de investigación HM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesia, Medication-Induced
• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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).

Locations

Country	Name	City	State
Spain	CINAC, Hospital Universitario Puerta del Sur	Móstoles	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Fundación de investigación HM	Hospital Nacional de Parapléjicos de Toledo, Hospital San Carlos, Madrid, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Dyskinesia severity evaluated for each body segment		Baseline, one day and one week after the end of treatment
Secondary	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
Secondary	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