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

Fundación de investigación HM

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease; Dyskinesia, Medication-Induced

Treatments: Device: tSMS; Device: sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02657681

9205 (Other Grant/Funding Number)

MJFOX-9205

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

tSMS

Experimental group

Description:

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

Treatment:

Device: tSMS

sham

Placebo Comparator group

Description:

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

Treatment:

Device: sham