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Parkinson DiseasePhase 1/2Parkinson'sNCT02917122

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

A Phase 1/2 study testing active tDCS and Sertraline in people with Parkinson Disease and Depression, run by National Cheng-Kung University Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Parkinson Disease, Depression
What is being tested?
active tDCS and Sertraline
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
No sites listed yet
Study dates
Aug 2015to Aug 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • 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.
  • 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).
  • 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.
  • Reported duration of the current episode is ≥4 weeks and has not been treated with antidepressants.
  • Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 at the screening (baseline) visit.
  • Is a man or woman aged 18 to 75 years, inclusive.

Who cannot join

  • Subjects known to have allergies to sertraline and pimozide.
  • Subjects showed any signs of substantial risk of suicide during the trial.
  • Subjects ever received electroconvulsive treatment.
  • Subjects co-morbid with other major mental disorders or with substance/alcohol dependence or abuse in the past 6 months per DSM-IV criteria.
  • Nursing women, pregnant women or patients suspected pregnant.
  • History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease that might compromise the study.
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  • History of seizure disorder or need to taking medications that increase the risk of seizure.
  • History or presence of dementia and any previous history of brain tumor, brain arteriovenous malformation, encephalitis or meningitis.
  • Subjects ever received or plan to receive brain surgery during the trial.
  • Subjects with pacemaker or are contraindicated for MRI.

About this study

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.

Read the 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.

Being tested
active tDCS, Sertraline, sham tDCS
Keywords
Parkinson disease, transcranial direct current stimulation, depression, dopamine transporter, single photon emission computerized tomography
Medical subject headings
Parkinson Disease, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active tDCSDevice

    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.

  • SertralineDrug

    Patients will take Sertraline.

  • sham tDCSDevice

    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.

Study groups in NCT02917122
Study groupRoleWhat they receive
sertraline + sham tDCSPlacebo comparatorPatients will take sham tDCS.
Receives: Drug: Sertraline; Device: sham tDCS
sertraline + active tDCSActive comparatorPatients 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.
Receives: Device: active tDCS; Drug: Sertraline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks

    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

    Measured: week 0 and 6

  2. Change of Hamilton Rating Scale for Depression Among Different Weeks

    Hamilton Rating Scale for Depression: summed, 0-50

    higher value is worse

    Measured: week 0 and 6

  3. Change of Taiwanese Depression Questionnaire Among Different Weeks

    Taiwanese Depression Questionnaire: summed, 0-54

    higher value is worse

    Measured: week 0 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2021
  4. Study completionAug 2021

Why it stopped: Funding is insufficient.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02917122
Sponsor's protocol ID
A-BR-103-079
Acronym
Parkinson's
Status last verified
Sep 2021
First submitted
30 Jun 2016
Last updated
20 Oct 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing active tDCS and Sertraline in people with Parkinson Disease and Depression, run by National Cheng-Kung University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks (time frame: week 0 and 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02917122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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