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| Name | Class |
|---|---|
| Hospital Universitari de Bellvitge | OTHER |
| Consorci Sanitari del Maresme. Hospital Universitari de Mataró | OTHER |
| Parc Taulí Hospital Universitari | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated home tDCS | Experimental | Home tDCS applied over 3 weeks (42 sessions) |
|
| Conventional home tDCS | Active Comparator | Home tDCS applied over 9 weeks (42 sessions) |
|
| Conventional ambulatory tDCS | Active Comparator | Ambulatory tDCS applied over 9 weeks (42 sessions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2nd week of treatment. |
| MADRS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Adverse Effect |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ane Miren Gutiérrez Muto, PhD | Contact | +34960606200 | investigacion@ionclinics.com | |
| Ensayos Ionclincs | Contact | +34674059324 | ensayos@ionclinics.com |
| Name | Affiliation | Role |
|---|---|---|
| Ane Miren Gutiérrez Muto | Ionclinics & Deionics S.L. | Study Director |
| Mar Hernández Secorún | Ionclinics & Deionics S.L. | Study Chair |
| Gustavo Sarriá Córdoba |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08304 | Spain |
In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.
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Randomized, parallel, double-blind, multicentre clinical trial.
Recruited subjects will be randomised into three groups: conventional tDCS at a healthcare centre (control intervention), conventional tDCS at home, and accelerated tDCS at home (allocation ratio of 1:1:1).
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Although it is impossible to blind participants due to the nature of the study, the evaluator and statistician will be blinded.
|
| 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). |
|
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at 3 months post-treatment compared to baseline.
| 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. | 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. | 2nd week of treatment. |
| HDRS-17 | Mean score change based on Hamilton Depression Rating Scale (HDRS-17) scores of the three arms at 3 months compared to baseline compared to baseline. | 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm. |
| HARS | Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the treatment compared to baseline. | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. |
| HARS | Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the second week of treatment compared to baseline. | 2nd week of treatment. |
| HARS | Mean score change based on Hamilton Anxiety Rating Scale (HARS) scores of the three arms at 3 months compared to baseline compared to baseline. | 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm. |
| PHQ9 | Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the treatment compared to baseline. | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. |
| PHQ9 | Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the second week of treatment compared to baseline. | 2nd week of treatment. |
| PHQ9 | Mean score change based on Patient Health Questionnaire-9 (PHQ9) scores of the three arms at 3 months compared to baseline compared to baseline. | 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm. |
| Clinical Global Impression | Score based on Clinical Global Impression of the three arms at the end of the treatment. | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. |
| Clinical Global Impression | Score based on Clinical Global Impression of the three arms at the end of the second week of treatment. | 2nd week of treatment. |
| Clinical Global Impression | Score based on Clinical Global Impression of the three arms at 3 months compared to baseline. | 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm. |
A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
| 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. | Through study completion, an average of 2 years |
| Ionclinics & Deionics S.L. |
| Study Chair |
| Hospital Universitari de Mataró | Recruiting | Mataró | Barcelona | 08304 | Spain |
|
| Parc Taulí Hospital Universitari | Not yet recruiting | Sabadell | Barcelona | 08208 | Spain |
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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