The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease

Inje University1 site in 1 country26 target enrollmentFebruary 2019

ConditionsParkinson's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Inje University
Enrollment: 26
Locations: 1
Primary Endpoint: BDI score
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Depression is common in Parkinson's disease (PD), but the effective treatment is not established yet. tDCS is a non-invasive brain stimulation to modulate brain function. The tDCS on the depression in general population were already conducted, but not in PD. This study is to know whether transcranial direct current stimulation (tDCS) is effective for the treatment of depression in PD. Participant will be asked to visit three consecutive days for the non-invasive stimulation.

Registry

clinicaltrials.gov

Start Date

February 2019

End Date

December 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Inje University

Responsible Party

Principal Investigator

Sangjin Kim

Professor

Inje University

Eligibility Criteria

Inclusion Criteria

•UK Parkinson's disease brain bank criteria
•more than 19 years old
•Able to provide consent for the protocol
•Depression (based on DSM-IV criteria)

Exclusion Criteria

•Unpredictable symptom fluctuations
•Contraindication to tDCS (i) irritations, cuts, lesions in the brain (ii) any preexisting unstable medical conditions, or conditions that may increase the risk of stimulation such as uncontrolled epilepsy (iii) history of severe cranial trauma with alteration of the cranial anatomy or metallic intracranial implants (iv) history of seizure
•Subjects without the capacity to give informed consent
•If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension

Outcomes

Primary Outcomes

BDI score

Time Frame: (1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS

The changes of Beck depression inventory after tDCS

Secondary Outcomes

HDRS score((1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS)
MADRS score((1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS)
resting state functional MRI((1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS))