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

Primary Purpose

Parkinson's Disease

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

transcranial direct current stimulation (tDCS)

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inje university, Busan Paik HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real tDCS

Sham tDCS

Arm Description

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

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)

Outcomes

Primary Outcome Measures

BDI score

The changes of Beck depression inventory after tDCS

Secondary Outcome Measures

HDRS score

The changes of Hamilton Depression Rating Scale after tDCS

MADRS score

The changes of Mongomery-Asberg Depression Rating Scale after tDCS

resting state functional MRI

The changes of resting state functional MRI after tDCS

Full Information

NCT ID

NCT03227783

First Posted

July 17, 2017

Last Updated

October 22, 2018

Sponsor

Inje University

1. Study Identification

Unique Protocol Identification Number

NCT03227783

Brief Title

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

Official Title

The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2019 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inje University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, Parallel, Sham-controlled, single-blinded study

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real tDCS

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

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)

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation (tDCS)

Intervention Description

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

Primary Outcome Measure Information:

Title

BDI score

Description

The changes of Beck depression inventory after tDCS

Time Frame

(1) before the1st visit (within one month) (2) right after the 3rd tDCS (3) within one months after the 3rd tDCS

Secondary Outcome Measure Information:

Title

HDRS score

Description

The changes of Hamilton Depression Rating Scale after tDCS

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

Title

MADRS score

Description

The changes of Mongomery-Asberg Depression Rating Scale after tDCS

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

Title

resting state functional MRI

Description

The changes of resting state functional MRI after tDCS

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sang Jin Kim, MD, PhD

Phone

82-51-890-8954

jsk120@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Jin Kim, MD, PhD

Organizational Affiliation

Inje University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inje university, Busan Paik Hospital

City

Busan

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sang-jin Kim, professor

Phone

82-10-9525-6207

jsk120@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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