tDCS for Treatment of Depression in Parkinson's Disease

Study Overview
=================
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.

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

Conditions
-----------------
Idiopathic Parkinson Disease, Depression

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation
* Device: Sham Transcranial direct current stimulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Arm<br>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<br> <br> |
| Sham Comparator: Sham Arm<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation