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

Overview

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.

Full Title of Study: “The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Real tDCS
    • Constant weak electric currents through scalp via two electrodes will be delivered. Current intensity: 2mA, 20min/day
  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • HDRS score
    • Time Frame: (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
    • Time Frame: (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
    • Time Frame: (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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inje University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sangjin Kim, Professor – Inje University
  • Overall Official(s)
    • Sang Jin Kim, MD, PhD, Principal Investigator, Inje University
  • Overall Contact(s)
    • Sang Jin Kim, MD, PhD, 82-51-890-8954, jsk120@hanmail.net

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