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

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ClinicalTrials.gov Identifier: NCT02657681
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Hospital Nacional de Parapléjicos de Toledo
Hospital San Carlos, Madrid
Information provided by (Responsible Party):
Guglielmo Foffani, Fundación de investigación HM

Brief 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).

Condition or disease Intervention/treatment Phase
Dyskinesia, Medication-Induced Parkinson's Disease Device: tSMS Device: sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Actual Study Start Date : October 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657681


Locations
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Spain
CINAC, Hospital Universitario Puerta del Sur
Móstoles, Madrid, Spain, 28938
Sponsors and Collaborators
Fundación de investigación HM
Michael J. Fox Foundation for Parkinson's Research
Hospital Nacional de Parapléjicos de Toledo
Hospital San Carlos, Madrid
Investigators
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Principal Investigator: Guglielmo Foffani, PhD CINAC, Hospital Universitario HM Puerta del Sur

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Responsible Party: Guglielmo Foffani, Principal Investigator, Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT02657681     History of Changes
Other Study ID Numbers: MJFOX-9205
9205 ( Other Grant/Funding Number: Michael J. Fox Foundation )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs