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

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT03227783
• Lead Sponsor: Inje University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23
• Study Start: 2019-02
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real tDCS	transcranial direct current stimulation (tDCS)	* Constant weak electric currents through scalp via two electrodes will be delivered. * Current intensity: 2mA, 20min/day
Sham tDCS	transcranial direct current stimulation (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)

Primary Outcome Measures

Name	Time	Method
BDI score	(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 Outcome Measures

Name	Time	Method
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	The changes of Hamilton Depression Rating Scale after 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	The changes of Mongomery-Asberg Depression Rating Scale after 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)	The changes of resting state functional MRI after tDCS

Trial Locations

Locations (1)

Inje university, Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of