The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in PD

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227783
• Other study ID #: 17-0051
• Status: Recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2018
• Source: Inje University
• Contact: Sang Jin Kim, MD, PhD
• Phone: 82-51-890-8954
• Email: jsk120[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

• Dementia

• 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

Related Conditions & MeSH terms

• Depression
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• transcranial direct current stimulation (tDCS)
tDCS is one of non-invasive brain stimulation. Constant, low current is delivered to the specific brain areas to change brain plasticity.

Locations

Country	Name	City	State
Korea, Republic of	Inje university, Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDI score	The changes of Beck depression inventory after tDCS	(1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS
Secondary	HDRS score	The changes of Hamilton Depression Rating Scale after tDCS	(1) before the 1st visit (within one month) (2) right after 3rd tDCS, within 24 hours (3) within one months after the 3rd tDCS
Secondary	MADRS score	The changes of Mongomery-Asberg Depression Rating Scale after tDCS	(1) before the 1st visit (within one month) (2) right after the 3rd tDCS, within 24 hours (3) within one months after 3rd tDCS
Secondary	resting state functional MRI	The changes of resting state functional MRI after tDCS	(1) before the 1st visit (within one month) (2) after the 3rd tDCS, within 24 hours (on the same day as the 3rd tDCS)