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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang Jin Kim, MD, PhD; Phone Number: 82-51-890-8954; Email: jsk120@hanmail.net

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Inje university, busan paik hospital
    • Contact: Sang-jin kim, professor; Phone Number: 82-10-9525-6207; Email: jsk120@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real tDCS; Constant weak electric currents through scalp via two electrodes will be delivered.; Current intensity: 2mA, 20min/day	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.
Sham Comparator: Sham tDCS; a 1 mA current, for 30 s giving an initial sensation of tDCS while minimizing stimulatory effects; Ramp up and ramp down was over 10 s. (Ref. Loo CK et al., Br J Psychiatry 2012;200:52-9)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: Sang Jin Kim, MD, PhD, Inje University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 17-0051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No