Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country32 target enrollmentMarch 10, 2022

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment: 32
Locations: 1
Primary Endpoint: Reduction of dyskinesia
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia

Registry

clinicaltrials.gov

Start Date

March 10, 2022

End Date

March 10, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria and levodopa-induced dyskinesia;
•age between 30 and 80 years;
•ongoing therapy with levodopa;
•fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria

•patients unable to give informed consent;
•cognitive impairment (MMSE ≤ 24);
•history of epilepsy;
•pregnant women.

Outcomes

Primary Outcomes

Reduction of dyskinesia

Time Frame: 15 days

Change in the total score of part III of the Unified Dyskinesia Rating Scale (range 0-112, 112 is the worse outcome) in on motor state at the assessment made three days after the end of treatment compared with the assessment made at baseline in the groups of patients treated with tDCS and sham-stimulation, respectively