tDCS for Treatment of Depression in Parkinson's Disease

November 9, 2016 updated by: Pedro Caldana Gordon, Hospital Santa Marcelina

Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial

Investigation of possible benefits of transcranial direct current stimulation (tDCS) as a treatment of depression in patients with Parkinson's Disease, through a randomized placebo-controlled clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We aim to investigate the effects of transcranial direct current stimulation (tDCS) as treatment for depression in patients with Parkinson's Disease. We have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tDCS during 1 week (3 sessions a day, with 30 minutes interval in between). Subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). The collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. Subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome.

We aim to enroll 50 subjects, 25 for each arm. The sample size calculation took into consideration previous clinical trials using tDCS for depression in different settings.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Hospital Santa Marcelina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Gordon, MD
        • Sub-Investigator:
          • Maria Sheila Rocha, MD, PhD
        • Sub-Investigator:
          • Jamana Barbosa

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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic Parkinson's Disease
  • Geriatric Depression Scale - 15 higher that 5
  • Major Depression Disorder

Exclusion Criteria:

  • CNS disease other than Parkinson's Disease (i.e. epilepsy, stroke)
  • Mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia)
  • Previous neurosurgical intervention (i.e. DBS)
  • Current use of antidepressant drug
  • High suicidality risk
  • Limited capacity of understanding written and spoken Portuguese

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Arm
Active sessions will involve the placement of the anode over the scalp corresponding to the F3 (10-20 EEG system), and cathode over F4. Current intensity will be 2mA, and the stimulation will last for 20 minutes.
Device: Transcranial direct current stimulation
Sham Comparator: Sham Arm
Sham stimulation will follow the same procedure as the Active, however after 30 seconds of stimulation, the current is turned off, mimicking the initial sensation of the tDCS session but providing no clinical or physiological effect.
Device: Sham Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Rating Scale for Depression
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale
Time Frame: 8 weeks
8 weeks
Mini-Mental State Examination
Time Frame: 8 weeks
8 weeks
Hamilton Anxiety Rating Scale
Time Frame: 8 weeks
8 weeks
Geriatric Depression Scale -15
Time Frame: 8 weeks
8 weeks
Parkinson's Disease Questionnaire - 39
Time Frame: 8 weeks
8 weeks
Lille apathy rating scale
Time Frame: 8 weeks
8 weeks
Quantitative EEG
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Hospital Santa Marcelina

Investigators

  • Study Director: Maria Sheila Rocha, MD, PhD, Hospital Santa Marcelina

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

October 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSMarcelina

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.

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