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

NCT ID: NCT03227783

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Parallel, Sham-controlled, single-blinded study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real tDCS

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

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

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)

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inje University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sangjin Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sang Jin Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inje university, Busan Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sang Jin Kim, MD, PhD

Role: CONTACT

82-51-890-8954

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sang-jin Kim, professor

Role: primary

82-10-9525-6207

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-0051

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.