tDCS for Treatment of Depression in Parkinson's Disease

Not Applicable

• Conditions: Idiopathic Parkinson Disease; Depression
• Interventions: Device: Sham Transcranial direct current stimulation; Device: Transcranial direct current stimulation

• Registration Number: NCT02960464
• Lead Sponsor: Hospital Santa Marcelina

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.

Study Timeline

• Study Start: 2016-10
• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Arm	Sham Transcranial direct current stimulation	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.
Active Arm	Transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Santa Marcelina; 🇧🇷 Sao Paulo, Brazil