Clinical trial NCT02960464: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Parkinson Disease
Depression
Keywords: Parkinson Disease
Depression
Transcranial Direct Current Stimulation
Neuromodulation
Lead sponsor: Hospital Santa Marcelina
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 8 weeks
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: 8 weeks
measure: Mini-Mental State Examination
timeFrame: 8 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 8 weeks
measure: Geriatric Depression Scale -15
timeFrame: 8 weeks
measure: Parkinson's Disease Questionnaire - 39
timeFrame: 8 weeks
measure: Lille apathy rating scale
timeFrame: 8 weeks
measure: Quantitative EEG
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina
Study officials:
affiliation: Hospital Santa Marcelina
name: Maria Sheila Rocha, MD, PhD
role: STUDY_DIRECTOR
References: