Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias
1 other identifier
interventional
32
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Mar 2022
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2025
CompletedMarch 31, 2023
February 1, 2023
1.8 years
February 21, 2023
March 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Active stimulation
EXPERIMENTALTen sessions of cathodic transcranial direct current stimulation over primary motor cortex
Sham stimulation
SHAM COMPARATORTen sessions of sham stimulation over primary motor cortex
Interventions
Ten sessions of transcranial direct current stimulation over primary motor cortex to treat levodopa-induced dyskinesia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- patients unable to give informed consent;
- cognitive impairment (MMSE ≤ 24);
- history of epilepsy;
- pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Flavia Torlizzi
Rome, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 2, 2023
Study Start
March 10, 2022
Primary Completion
December 30, 2023
Study Completion
March 10, 2025
Last Updated
March 31, 2023
Record last verified: 2023-02