Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT05752240
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-02
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-12-30
• Study Completion: 2025-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of dyskinesia	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

Trial Locations

Locations (1)

Flavia Torlizzi; 🇮🇹 Rome, Italy