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

Fundación de investigación HM1 site in 1 country50 target enrollmentOctober 2015

ConditionsDyskinesia, Medication-Induced Parkinson's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Dyskinesia, Medication-Induced
Sponsor: Fundación de investigación HM
Enrollment: 50
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

September 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundación de investigación HM

Responsible Party

Principal Investigator

Guglielmo Foffani

Principal Investigator

Fundación de investigación HM

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

Outcomes

Primary Outcomes

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 Outcomes

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)