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Clinical Trials/NCT05752240
NCT05752240UnknownNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country32 target enrollmentStarted: March 10, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
32
Locations
1
Primary Endpoint
Reduction of dyskinesia

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
30 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Active stimulation

Experimental

Ten sessions of cathodic transcranial direct current stimulation over primary motor cortex

Intervention: Transcranial direct current stimulation (Device)

Sham stimulation

Sham Comparator

Ten sessions of sham stimulation over primary motor cortex

Intervention: Transcranial direct current stimulation (Device)

Outcomes

Primary Outcomes

Reduction of dyskinesia

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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