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

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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : August 2021
Actual Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


  2. 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


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

    Taiwanese Depression Questionnaire: summed, 0-54

    higher value is worse



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917122


Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Study Chair: Kao Chin Chen, PhD National Cheng-Kung University Hospital
  Study Documents (Full-Text)

Documents provided by Kao Chin, Chen, National Cheng-Kung University Hospital:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 21, 2017

More Information
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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: September 28, 2016    Key Record Dates
Results First Posted: October 20, 2021
Last Update Posted: October 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kao Chin, Chen, National Cheng-Kung University Hospital:
Parkinson disease
transcranial direct current stimulation
depression
dopamine transporter
single photon emission computerized tomography
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Synucleinopathies
Neurodegenerative Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs