Trial Outcomes & Findings for The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease (NCT NCT02917122)
NCT ID: NCT02917122
Last Updated: 2021-10-20
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
week 0 and 6
Results posted on
2021-10-20
Participant Flow
Participant milestones
| Measure |
Sertraline + Sham tDCS
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.
|
Sertraline + 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.
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 Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Sertraline + Sham tDCS
n=8 Participants
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.
|
Sertraline + Active tDCS
n=7 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.00 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
61.86 years
STANDARD_DEVIATION 9.82 • n=7 Participants
|
61.93 years
STANDARD_DEVIATION 8.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 0 and 6mds: 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
Outcome measures
| Measure |
Sertraline + Sham tDCS
n=6 Participants
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.
|
Sertraline + Active tDCS
n=4 Participants
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.
|
|---|---|---|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds1 non-motor experiences of daily living-week0
|
9.00 score on a scale
Standard Deviation 5.48
|
10.00 score on a scale
Standard Deviation 4.83
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds1 non-motor experiences of daily living-week6
|
6.17 score on a scale
Standard Deviation 3.43
|
8.25 score on a scale
Standard Deviation 3.10
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds2 motor experiences of daily living-week0
|
5.33 score on a scale
Standard Deviation 3.50
|
2.25 score on a scale
Standard Deviation 2.06
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds2 motor experiences of daily living-week6
|
2.17 score on a scale
Standard Deviation 1.33
|
4.75 score on a scale
Standard Deviation 3.20
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds3 motor examination-week0
|
23.50 score on a scale
Standard Deviation 12.93
|
18.75 score on a scale
Standard Deviation 6.40
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds3 motor examination-week6
|
22.17 score on a scale
Standard Deviation 10.34
|
19.50 score on a scale
Standard Deviation 5.00
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds4 motor complications-week0
|
0.50 score on a scale
Standard Deviation 1.22
|
2.75 score on a scale
Standard Deviation 3.77
|
|
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
mds4 motor complications-week6
|
1.00 score on a scale
Standard Deviation 1.55
|
1.25 score on a scale
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: week 0 and 6Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse
Outcome measures
| Measure |
Sertraline + Sham tDCS
n=5 Participants
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.
|
Sertraline + Active tDCS
n=6 Participants
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.
|
|---|---|---|
|
Change of Hamilton Rating Scale for Depression Among Different Weeks
week0
|
21.83 score on a scale
Standard Deviation 4.79
|
27.40 score on a scale
Standard Deviation 4.22
|
|
Change of Hamilton Rating Scale for Depression Among Different Weeks
week6
|
5.83 score on a scale
Standard Deviation 4.36
|
10.20 score on a scale
Standard Deviation 7.69
|
PRIMARY outcome
Timeframe: week 0 and 6Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse
Outcome measures
| Measure |
Sertraline + Sham tDCS
n=6 Participants
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.
|
Sertraline + Active tDCS
n=5 Participants
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.
|
|---|---|---|
|
Change of Taiwanese Depression Questionnaire Among Different Weeks
week0
|
25.50 score on a scale
Standard Deviation 11.64
|
24.80 score on a scale
Standard Deviation 11.19
|
|
Change of Taiwanese Depression Questionnaire Among Different Weeks
week6
|
14.83 score on a scale
Standard Deviation 12.34
|
18.60 score on a scale
Standard Deviation 16.01
|
Adverse Events
Sertraline + Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sertraline + Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place