Depression Clinical Trial
Official title:
Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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