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

September 22, 2021 updated by: Kao Chin, Chen, National Cheng-Kung University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Sertraline
Patients will take Sertraline.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks
Time Frame: 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
week 0 and 6
Change of Hamilton Rating Scale for Depression Among Different Weeks
Time Frame: week 0 and 6

Hamilton Rating Scale for Depression: summed, 0-50

higher value is worse
week 0 and 6
Change of Taiwanese Depression Questionnaire Among Different Weeks
Time Frame: week 0 and 6

Taiwanese Depression Questionnaire: summed, 0-54

higher value is worse
week 0 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-103-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe