NCT02657681

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

January 14, 2016

Last Update Submit

October 10, 2018

Conditions

Dyskinesia, Medication-InducedParkinson's Disease

Outcome Measures

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.

    One day after the end of treatment compared to baseline

Secondary Outcomes (4)

  • 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

Study Arms (2)

tSMS

EXPERIMENTAL

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

Device: tSMS

sham

PLACEBO COMPARATOR

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

Device: sham

Interventions

tSMSDEVICE

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.

Also known as: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)
tSMS
shamDEVICE

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).

Also known as: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
sham

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
  • other main neuropsychiatric co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINAC, Hospital Universitario Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

MeSH Terms

Conditions

Dyskinesia, Drug-InducedParkinson Disease

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoningParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Guglielmo Foffani, PhD

    CINAC, Hospital Universitario HM Puerta del Sur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

ES(1)