Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease: a Double-blind Randomized Controlled Clinical Trial.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05752240

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Transcranial direct current stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease: a Double-blind Randomized Controlled Clinical Trial.

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Mar 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active stimulation	Device: Transcranial direct current stimulation Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia
Sham Comparator: Sham stimulation	Device: Transcranial direct current stimulation Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia

Arm

Intervention/Treatment

Experimental: Active stimulation

Device: Transcranial direct current stimulation

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

Sham Comparator: Sham stimulation

Device: Transcranial direct current stimulation

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

Outcome Measures

Primary Outcome Measures

Reduction of dyskinesia [15 days]
Reduction in the total score of part III of the UDyRS scale in on motor 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Flavia Torlizzi	Rome		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05752240

Other Study ID Numbers:

3944

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Dyskinesias

Study Results

No Results Posted as of Mar 2, 2023