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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752240
• Other study ID #: 3944
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: March 10, 2025

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Francesco Bove, MD
• Phone: +390630156433
• Email: francesco.bove[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 10, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Device:
• Transcranial direct current stimulation
Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia

Locations

Country	Name	City	State
Italy	Flavia Torlizzi	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of dyskinesia	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	15 days