Home tDCS for the Treatment of Major Depression.

ConditionMajor Depression Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorIonclinics & Deionic SL

About this trial

The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol.

The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spanish or Catalan speakers of both sexes between the ages of 18 and 65.

Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).

Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.

Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.

Disqualifiers

Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).

Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).

Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.

Patients with dermatological problems, such as an allergic skin reaction at the electrode site.

Trial design

Design model

Parallel

Treatments tested in this trial

Accelerated protocol of home Transcranial direct current stimulation
Device
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
Conventional protocol of home Transcranial direct current stimulation
Device
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
Conventional protocol of in person Transcranial direct current stimulation
Device
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).

Treatment groups

198 Participants

are divided into 3 treatment groups

Group A: Accelerated home tDCSExperimental treatment 1 intervention

Group B: Conventional home tDCSActive comparator 1 intervention

Group C: Conventional ambulatory tDCSActive comparator 1 intervention

Trial outcomes

Primary outcomes

MADRS

Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline.

Time frame

End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.

Secondary outcomes

MADRS

Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the second week of treatment compared to baseline.

Time frame

2nd week of treatment.

MADRS

Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at 3 months post-treatment compared to baseline.

Time frame

3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.

HDRS-17

Mean score change based on Hamilton Depression Rating Scale (HDRS) of the three arms at the end of the treatment compared to baseline.

Time frame

End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.

HDRS-17

Mean score change based on Hamilton Depression Rating Scale (HDRS-17) of the three arms at the end of the second week of treatment compared to baseline.

Time frame

2nd week of treatment.

Other outcomes

Patient Expectations

Likert scale from 1 to 5 (where 1 is no expectation and 5 is the highest possible expectation) to study the influence of expectation on the effect of treatment.

Time frame

Baseline

Adverse Effect

A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.

Time frame

End-of-day application (Experimental: from Monday to Sunday through 3 weeks; Active Comparator: From Monday to Friday, through 9 weeks).

Success of the blinding

A method 2 x 3 will be used to evaluate the success of the study's evaluator and statistician.

Time frame

Through study completion, an average of 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ionclinics & Deionic SL

Lead sponsor

Hospital Universitari de Bellvitge

Collaborator

Consorci Sanitari del Maresme. Hospital Universitari de Mataró

Collaborator

Parc Taulí Hospital Universitari

Collaborator

Source ClinicalTrials.gov

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