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)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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
Email
jsk120@hanmail.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Transcranial Direct Current Stimulation (tDCS) on Depression in PD
We'll reach out to this number within 24 hrs