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tDCS for Treatment of Depression in Parkinson's Disease

NCT ID: NCT02960464

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Idiopathic Parkinson Disease Depression

Keywords

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Parkinson Disease Depression Transcranial Direct Current Stimulation Neuromodulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Sham Transcranial direct current stimulation

Intervention Type DEVICE

Interventions

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Transcranial direct current stimulation

Intervention Type DEVICE

Sham Transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Santa Marcelina

OTHER

Sponsor Role lead

Responsible Party

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Pedro Caldana Gordon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Sheila Rocha, MD, PhD

Role: STUDY_DIRECTOR

Hospital Santa Marcelina

Locations

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Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jamana Barbosa

Role: CONTACT

Phone: 2070-6000

Email: [email protected]

Facility Contacts

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Pedro Gordon, MD

Role: primary

Maria Sheila Rocha, MD, PhD

Role: backup

Other Identifiers

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HSMarcelina

Identifier Type: -

Identifier Source: org_study_id