An interventional study of Transcranial direct current stimulation and Sham Transcranial direct current stimulation in Idiopathic Parkinson Disease and Depression, sponsored by Hospital Santa Marcelina. Status unknown at 1 site in Brazil. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-10.
Sponsored by Hospital Santa Marcelina · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Hospital Santa Marcelina as lead sponsor.
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Exclusion Criteria:
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
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
Hamilton Rating Scale for Depression
Time frame: 8 weeks
Montgomery-Åsberg Depression Rating Scale
Time frame: 8 weeks
Mini-Mental State Examination
Time frame: 8 weeks
Hamilton Anxiety Rating Scale
Time frame: 8 weeks
Geriatric Depression Scale -15
Time frame: 8 weeks
Parkinson's Disease Questionnaire - 39
Time frame: 8 weeks
Lille apathy rating scale
Time frame: 8 weeks
Quantitative EEG
Time frame: 8 weeks
Plan to share: No
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This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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