Back to results

tDCS for Treatment of Depression in Parkinson's Disease

Primary Purpose

Idiopathic Parkinson Disease, Depression

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Transcranial direct current stimulation

Sham Transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease focused on measuring Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Santa MarcelinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Arm

Sham Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Montgomery-Åsberg Depression Rating Scale

Mini-Mental State Examination

Hamilton Anxiety Rating Scale

Geriatric Depression Scale -15

Parkinson's Disease Questionnaire - 39

Lille apathy rating scale

Quantitative EEG

Full Information

NCT ID

NCT02960464

First Posted

November 8, 2016

Last Updated

November 9, 2016

Sponsor

Hospital Santa Marcelina

1. Study Identification

Unique Protocol Identification Number

NCT02960464

Brief Title

tDCS for Treatment of Depression in Parkinson's Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Santa Marcelina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson Disease, Depression

Keywords

Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Arm

Arm Type

Active Comparator

Arm Description

Arm Title

Sham Arm

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Intervention Type

Device

Intervention Name(s)

Sham Transcranial direct current stimulation

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Montgomery-Åsberg Depression Rating Scale

Time Frame

8 weeks

Title

Mini-Mental State Examination

Time Frame

8 weeks

Title

Hamilton Anxiety Rating Scale

Time Frame

8 weeks

Title

Geriatric Depression Scale -15

Time Frame

8 weeks

Title

Parkinson's Disease Questionnaire - 39

Time Frame

8 weeks

Title

Lille apathy rating scale

Time Frame

8 weeks

Title

Quantitative EEG

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jamana Barbosa

Phone

2070-6000

jamana.bp@ig.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Sheila Rocha, MD, PhD

Organizational Affiliation

Hospital Santa Marcelina

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Santa Marcelina

City

Sao Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Gordon, MD

dr.pedrogordon@gmail.com

First Name & Middle Initial & Last Name & Degree

Maria Sheila Rocha, MD, PhD

msrocha@uol.com.br

First Name & Middle Initial & Last Name & Degree

Pedro Gordon, MD

First Name & Middle Initial & Last Name & Degree

Maria Sheila Rocha, MD, PhD

First Name & Middle Initial & Last Name & Degree

Jamana Barbosa

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

tDCS for Treatment of Depression in Parkinson's Disease

We'll reach out to this number within 24 hrs