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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02960464

Enrollment

Registered

2016-11-09

Start date

2016-10-31

Completion date

Unknown

Last updated

2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Idiopathic Parkinson Disease

Keywords

Parkinson Disease, Depression, Transcranial Direct Current Stimulation, Neuromodulation

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.

Detailed 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.

Interventions

DEVICETranscranial direct current stimulation

DEVICESham Transcranial direct current stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hamilton Rating Scale for Depression	8 weeks

Secondary

Measure	Time frame
Mini-Mental State Examination	8 weeks
Hamilton Anxiety Rating Scale	8 weeks
Geriatric Depression Scale -15	8 weeks
Montgomery-Åsberg Depression Rating Scale	8 weeks
Lille apathy rating scale	8 weeks
Quantitative EEG	8 weeks
Parkinson's Disease Questionnaire - 39	8 weeks

Countries

Brazil

Contacts

Primary ContactJamana Barbosa

jamana.bp@ig.com.br2070-6000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026