tDCS for Treatment of Depression in Parkinson's Disease
Transcranial Direct Current Stimulation for Treatment of Depression in Parkinson's Disease, a Randomized Placebo-controlled Clinical Trial
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedNovember 10, 2016
November 1, 2016
1.7 years
November 8, 2016
November 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Rating Scale for Depression
8 weeks
Secondary Outcomes (7)
Montgomery-Åsberg Depression Rating Scale
8 weeks
Mini-Mental State Examination
8 weeks
Hamilton Anxiety Rating Scale
8 weeks
Geriatric Depression Scale -15
8 weeks
Parkinson's Disease Questionnaire - 39
8 weeks
- +2 more secondary outcomes
Study Arms (2)
Active Arm
ACTIVE COMPARATORActive 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.
Sham Arm
SHAM COMPARATORSham 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.
Interventions
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's Disease
- Geriatric Depression Scale - 15 higher that 5
- Major Depression Disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Sheila Rocha, MD, PhD
Hospital Santa Marcelina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 8, 2016
First Posted
November 9, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2018
Last Updated
November 10, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share