Designing a Transcranial Direct Current Stimulation (tDCS) device and its clinical certification through a randomized double-blind controlled trial in depressive patients

Designing a Transcranial Direct Current Stimulation (tDCS) device and its clinical certification through a randomized double-blind controlled trial in depressive patients - e-bolt

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012525

Enrollment

Registered

2017-06-07

Start date

2017-06-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F32 F33

Interventions

Group 1: Active anodal stimulation of left dorsolateral prefrontal cortex (F3 position, according to the International 10–20 system for standardized placement of electroencephalogram/EEG electrodes),

sham anode position: F3, according to the International 10–20 system for standardized placement of electroencephalogram (EEG) electrodes.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Clinical Major Depressive disorder, unipolar - both clinical assessment and Mini Neuropsychiatric Interview confirmation. - No active treatment in use - Hamilton D-17 score above 19 - older than 18, both sexes - Capacity to understand and sign the consent form

Exclusion criteria

Exclusion criteria: - somatic illness not stabilized in the last 3 months prior to first assessment - High suicide risk - Dementia - Diagnosis of Bipolar Affective Disorder - Impaired capacity to consent - Personality disorders - Substance misuse disorders - Abnormal blood exams for more than 2 weeks - Homelessness - History of non compliance with treatment

Design outcomes

Primary

Measure	Time frame
Eventual improvement in depressive symptoms will be measured by Hamilton Depression Scale (17 items) scores. Both groups will be assessed before intervention (maximum allowed interval - 1 week) and after 10 sessions (within 1 week).	—

Secondary

Measure	Time frame
Eventual improvement of quality of life will be measured by WHO-QoL-BREF scale -both groups will be assessed before intervention (maximum allowed interval - 1 week) and after 10 sessions (within 1 week). Eventual improvement in depressive symptoms will be measured by Beck Depression Inventory - both groups will be assessed before intervention (maximum allowed interval - 1 week) and after 10 sessions (within 1 week). Treatment satisfaction and adverse reactions will be measured by TSQM II- Treatment Satisfaction Questionnaire for Medication – version II, in both groups within 1 week after intervention.	—

Measure

Time frame

Eventual improvement of quality of life will be measured by WHO-QoL-BREF scale -both groups will be assessed before intervention (maximum allowed interval - 1 week) and after 10 sessions (within 1 week). Eventual improvement in depressive symptoms will be measured by Beck Depression Inventory - both groups will be assessed before intervention (maximum allowed interval - 1 week) and after 10 sessions (within 1 week). Treatment satisfaction and adverse reactions will be measured by TSQM II- Treatment Satisfaction Questionnaire for Medication – version II, in both groups within 1 week after intervention.

—

Countries

Brazil

Contacts

Public ContactRafael Bernardon Ribeiro

Santa Casa Medical School, São Paulo - Brazil

pesquisa@sospsiquiatria.com551134662100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026