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

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02917122
• Collaborator: (none)
• Enrollment: 15
• Arms: 2
• Duration (Months): 72

Study Details

Study Description

Brief Summary

Parkinson's disease (PD) is one of the most common neurological diseases manifested by movement disturbance. The concomitant psychiatric symptoms, especially depression, are often observed and have also great impact on patients' quality of life. The treatment of depressive symptoms in PD with antidepressants as the majority remains variable and inefficient, which complicates the disease prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive brain modulation technique and has been demonstrated to improve psychiatric diseases such as major depression. In this study the investigators will assess the combined effects of tDCS on sertraline for the treatment of depression in PD. Ten sessions of tDCS in two weeks will be applied and the follow-up evaluation will continue bi-weekly for one month after completing all sessions. The efficacy of tDCS vs sertraline will be compared and evaluated with behavioral and cognitive outcome. In addition, the investigators will evaluate if the baseline dopaminergic activity in brain could predict the treatment outcome by using SPECT imaging. The investigators aim to establish the therapeutic parameters and safety criteria of tDCS as an add-on or alternative therapy, and further enhance the overall clinical efficacy in the treatment of depression in PD.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Depression	Device: active tDCS; Drug: Sertraline; Device: sham tDCS	Phase 1/Phase 2

Detailed Description

Study design

This study is a factorial randomized, placebo-control trial, including 2 groups: 'sertraline only' (sertraline + sham tDCS), and 'combined treatment' (sertraline + active tDCS). It is planned to recruit 20 subjects for each group, which results in all together 40 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. Both pharmacological and tDCS intervention will be started simultaneously on the first day of the treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: sertraline + sham tDCS Patients will take sham tDCS.	Drug: Sertraline; Patients will take Sertraline.; Device: 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.
Active Comparator: 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.	Device: 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.; Drug: Sertraline; Patients will take Sertraline.

Outcome Measures

Primary Outcome Measures

1. Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks [week 0 and 6]

   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

2. Change of Hamilton Rating Scale for Depression Among Different Weeks [week 0 and 6]

   Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse

3. Change of Taiwanese Depression Questionnaire Among Different Weeks [week 0 and 6]

   Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

3. Suffers from Parkinson's disease fulfill the Parkinson's Disease Society Brain Bank clinical criteria with insidious 2 or more PD symptoms (bradykinesia, tremor, or rigidity).

4. Suffers from "DSM-IV major depressive disorder, single episode" or "DSM-IV major depressive disorder, recurrent" according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria.

5. Reported duration of the current episode is ≥4 weeks and has not been treated with antidepressants.

6. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 at the screening (baseline) visit.

7. Is a man or woman aged 18 to 75 years, inclusive.

Exclusion criteria:

1. Subjects known to have allergies to sertraline and pimozide.

2. Subjects showed any signs of substantial risk of suicide during the trial.

3. Subjects ever received electroconvulsive treatment.

4. Subjects co-morbid with other major mental disorders or with substance/alcohol dependence or abuse in the past 6 months per DSM-IV criteria.

5. Nursing women, pregnant women or patients suspected pregnant.

6. History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease that might compromise the study.

7. History of seizure disorder or need to taking medications that increase the risk of seizure.

8. History or presence of dementia and any previous history of brain tumor, brain arteriovenous malformation, encephalitis or meningitis.

9. Subjects ever received or plan to receive brain surgery during the trial.

10. Subjects with pacemaker or are contraindicated for MRI.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Cheng-Kung University Hospital

Investigators

• Study Chair: Kao Chin Chen, PhD, National Cheng-Kung University Hospital

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 21, 2017

More Information

Publications

None provided.

• Responsible Party: Kao Chin, Chen, assistant professor, National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT02917122
• Other Study ID Numbers: A-BR-103-079
• First Posted: Sep 28, 2016
• Last Update Posted: Oct 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kao Chin, Chen, assistant professor, National Cheng-Kung University Hospital: Parkinson disease; transcranial direct current stimulation; depression; dopamine transporter; single photon emission computerized tomography
• Additional relevant MeSH terms: Parkinson Disease; Depression; Depressive Disorder; Sertraline

Study Results

Participant Flow

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 Participants	8	7	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.00 (8.50)	61.86 (9.82)	61.93 (8.80)
Sex: Female, Male (Count of Participants)
Female	8 100%	3 42.9%	11 73.3%
Male	0 0%	4 57.1%	4 26.7%
Race/Ethnicity, Customized (Count of Participants)
Asian	8 100%	7 100%	15 100%

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.
Measure Participants	6	4
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.
Measure Participants	5	6
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.
Measure Participants	6	5
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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Serious Adverse Events
	Sertraline + Sham tDCS		Sertraline + Active tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Sertraline + Sham tDCS		Sertraline + Active tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)

Limitations/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.