tDCS for Treatment of Depression in Parkinson's Disease

Depression Clinical Trial

Official title:

Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960464
• Other study ID #: HSMarcelina
• 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. 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Idiopathic Parkinson Disease
• Parkinson Disease

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