tDCS for Treatment of Depression in Parkinson's Disease

Santa Marcelina Hospital

Status: Unknown

Conditions: Idiopathic Parkinson Disease; Depression

Treatments: Device: Sham Transcranial direct current stimulation; Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02960464

HSMarcelina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Active Arm

Active Comparator group

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.

Treatment:

Device: Transcranial direct current stimulation

Sham Arm

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial direct current stimulation