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

• ClinicalTrials.gov Identifier: NCT02917122
• Recruitment Status: Terminated
• First Posted: September 28, 2016
• Results First Posted: October 20, 2021
• Last Update Posted: October 20, 2021
• Sponsor: National Cheng-Kung University Hospital
• Information provided by (Responsible Party): Kao Chin, Chen, National Cheng-Kung University Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Parkinson Disease; Depression
• Interventions: Device: active tDCS; Drug: Sertraline; Device: sham tDCS
• Enrollment: 15

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Sertraline + Sham tDCS	Sertraline + Active tDCS
Arm/Group Description	Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.
Period Title: Overall Study
Started	8	7
Completed	8	7
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Sertraline + Sham tDCS	Sertraline + Active tDCS	Total
Arm/Group Description		Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.	Total of all reporting groups
Overall Number of Baseline Participants		8	7	15
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	8 participants	7 participants	15 participants
		62.00 (8.50)	61.86 (9.82)	61.93 (8.80)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	8 participants	7 participants	15 participants
	Female	8	3	11
	Male	0	4	4
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Asian	Number Analyzed	8 participants	7 participants	15 participants
		8	7	15

Outcome Measures

1. Primary Outcome

Title	Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
Description	mds: modified-Unified Parkinson's Disease mds1 non-motor experiences of daily living: summed, 0-52 mds2 motor experiences of daily living: summed, 0-52 mds3 motor examination: summed, 0-132 mds4 motor complications: summed, 0-24 higher value is worse
Time Frame	week 0 and 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline + Sham tDCS	Sertraline + Active tDCS
Arm/Group Description:	Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.
Overall Number of Participants Analyzed	6	4
Mean (Standard Deviation); Unit of Measure: score on a scale
mds1 non-motor experiences of daily living-week0	9.00 (5.48)	10.00 (4.83)
mds1 non-motor experiences of daily living-week6	6.17 (3.43)	8.25 (3.10)
mds2 motor experiences of daily living-week0	5.33 (3.50)	2.25 (2.06)
mds2 motor experiences of daily living-week6	2.17 (1.33)	4.75 (3.20)
mds3 motor examination-week0	23.50 (12.93)	18.75 (6.40)
mds3 motor examination-week6	22.17 (10.34)	19.50 (5.00)
mds4 motor complications-week0	0.50 (1.22)	2.75 (3.77)
mds4 motor complications-week6	1.00 (1.55)	1.25 (2.50)

2. Primary Outcome

Title	Change of Hamilton Rating Scale for Depression Among Different Weeks
Description	Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse
Time Frame	week 0 and 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline + Sham tDCS	Sertraline + Active tDCS
Arm/Group Description:	Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.
Overall Number of Participants Analyzed	5	6
Mean (Standard Deviation); Unit of Measure: score on a scale
week0	21.83 (4.79)	27.40 (4.22)
week6	5.83 (4.36)	10.20 (7.69)

3. Primary Outcome

Title	Change of Taiwanese Depression Questionnaire Among Different Weeks
Description	Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse
Time Frame	week 0 and 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline + Sham tDCS	Sertraline + Active tDCS
Arm/Group Description:	Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.
Overall Number of Participants Analyzed	6	5
Mean (Standard Deviation); Unit of Measure: score on a scale
week0	25.50 (11.64)	24.80 (11.19)
week6	14.83 (12.34)	18.60 (16.01)

Adverse Events

Time Frame	week -1, 0, 2, 4, 6
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Sertraline + Sham tDCS	Sertraline + Active tDCS
Arm/Group Description	Patients will take sham tDCS. Sertraline: Patients will take Sertraline. sham tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.	Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. active tDCS: Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Sertraline: Patients will take Sertraline.
All-Cause Mortality
	Sertraline + Sham tDCS	Sertraline + Active tDCS
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/7 (0.00%)
Serious Adverse Events
	Sertraline + Sham tDCS	Sertraline + Active tDCS
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/7 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Sertraline + Sham tDCS	Sertraline + Active tDCS
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/7 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Kao Chin Chen
• Organization: National Cheng Kung University
• Phone: +886-6-2353535 ext 5213
• EMail: andchen@mail.ncku.edu.tw

• Responsible Party: Kao Chin, Chen, National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT02917122
• Other Study ID Numbers: A-BR-103-079
• First Submitted: June 30, 2016
• First Posted: September 28, 2016
• Results First Submitted: August 26, 2021
• Results First Posted: October 20, 2021
• Last Update Posted: October 20, 2021