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

Primary Purpose

Dyskinesia, Medication-Induced, Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
tSMS
sham
Sponsored by
Fundación de investigación HM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyskinesia, Medication-Induced

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CINAC, Hospital Universitario Puerta del Sur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tSMS

sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Dyskinesia severity evaluated for each body segment
Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)
Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale

Full Information

First Posted
January 14, 2016
Last Updated
October 10, 2018
Sponsor
Fundación de investigación HM
Collaborators
Michael J. Fox Foundation for Parkinson's Research, Hospital Nacional de Parapléjicos de Toledo, Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02657681
Brief Title
Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Official Title
Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación de investigación HM
Collaborators
Michael J. Fox Foundation for Parkinson's Research, Hospital Nacional de Parapléjicos de Toledo, Hospital San Carlos, Madrid

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyskinesia, Medication-Induced, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tSMS
Arm Type
Experimental
Arm Description
30 min of tSMS, one session per day, for 9 days over 2 weeks
Arm Title
sham
Arm Type
Placebo Comparator
Arm Description
30 min of sham, one session per day, for 9 days over 2 weeks
Intervention Type
Device
Intervention Name(s)
tSMS
Other Intervention Name(s)
MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)
Intervention Description
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
Intervention Name(s)
sham
Other Intervention Name(s)
MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
Intervention Description
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).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Dyskinesia severity evaluated for each body segment
Time Frame
Baseline, one day and one week after the end of treatment
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guglielmo Foffani, PhD
Organizational Affiliation
CINAC, Hospital Universitario HM Puerta del Sur
Official's Role
Principal Investigator
Facility Information:
Facility Name
CINAC, Hospital Universitario Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain

12. IPD Sharing Statement

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

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