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

NCT03227783 | Unknown

• 1 other identifier: 17-0051
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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)

Study Arms (2)

Real tDCS

ACTIVE COMPARATOR

* Constant weak electric currents through scalp via two electrodes will be delivered. * Current intensity: 2mA, 20min/day

Device: transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

* 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)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

tDCS is one of non-invasive brain stimulation. Constant, low current is delivered to the specific brain areas to change brain plasticity.

Real tDCS; Sham tDCS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Inje university, Busan Paik Hospital

Busan, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sang Jin Kim, MD, PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Jin Kim, MD, PhD

CONTACT

82-51-890-8954; jsk120@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, Parallel, Sham-controlled, single-blinded study

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 24, 2017
• Study Start: February 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)