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

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ClinicalTrials.gov Identifier: NCT03227783
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sangjin Kim, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: transcranial direct current stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Parallel, Sham-controlled, single-blinded study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227783


Contacts
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Contact: Sang Jin Kim, MD, PhD 82-51-890-8954 jsk120@hanmail.net

Locations
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Korea, Republic of
Inje university, Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Sang-jin Kim, professor    82-10-9525-6207    jsk120@hanmail.net   
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Sang Jin Kim, MD, PhD Inje University

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Responsible Party: Sangjin Kim, Professor, Inje University
ClinicalTrials.gov Identifier: NCT03227783     History of Changes
Other Study ID Numbers: 17-0051
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases