Back to resultsTranscranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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.
Sites / Locations
- Flavia TorlizziRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active stimulation
Sham stimulation
Arm Description
Ten sessions of cathodic transcranial direct current stimulation over primary motor cortex
Ten sessions of sham stimulation over primary motor cortex
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05752240
First Posted
February 21, 2023
Last Updated
March 29, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05752240
Brief Title
Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias
Official Title
Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias in Patients With Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
Ten sessions of cathodic transcranial direct current stimulation over primary motor cortex
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Ten sessions of sham stimulation over primary motor cortex
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia
Primary Outcome Measure Information:
Title
Reduction of dyskinesia
Description
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
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Bove, MD
Phone
+390630156433
Email
francesco.bove@policlinicogemelli.it
Facility Information:
Facility Name
Flavia Torlizzi
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Torlizzi
Phone
+390630156433
Email
flavia.torlizzi@policlinicogemelli.it
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias
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