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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02960464
Other study ID # HSMarcelina
Secondary ID
Status Recruiting
Phase N/A
First received November 8, 2016
Last updated November 9, 2016
Start date October 2016

Study information

Verified date November 2016
Source Hospital Santa Marcelina
Contact Jamana Barbosa
Phone 2070-6000
Email jamana.bp@ig.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
Transcranial direct current stimulation

Sham Transcranial direct current stimulation


Locations

Country Name City State
Brazil Hospital Santa Marcelina Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Hospital Santa Marcelina

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression 8 weeks No
Secondary Montgomery-Åsberg Depression Rating Scale 8 weeks No
Secondary Mini-Mental State Examination 8 weeks No
Secondary Hamilton Anxiety Rating Scale 8 weeks No
Secondary Geriatric Depression Scale -15 8 weeks No
Secondary Parkinson's Disease Questionnaire - 39 8 weeks No
Secondary Lille apathy rating scale 8 weeks No
Secondary Quantitative EEG 8 weeks No
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