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

Phase 2

Completed

• Conditions: Dyskinesia, Medication-Induced; Parkinson's Disease
• Interventions: Device: tSMS; Device: sham

• Registration Number: NCT02657681
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tSMS	tSMS	30 min of tSMS, one session per day, for 9 days over 2 weeks
sham	sham	30 min of sham, one session per day, for 9 days over 2 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CINAC, Hospital Universitario Puerta del Sur; 🇪🇸 Móstoles, Madrid, Spain