Transcranial Direct Current Stimulation as Home Treatment in Depression

Study Overview
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Brief Summary
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In this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.

Detailed Description
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In this one-armed study at least 10 patients with depression will be included who will get treatment with transcranial direct currect stimulation at home. One visit in the hospital before and one visit after the treatment are necessary. The correct application of the device by the patients will be ensured by video counseling and monitoring. Treatment will last six weeks with 2 mA applied every working day for 20min with prefrontal montage. Aim of the study is the evaluation of the feasibility of this home treatment (usability of the device, compliance of patients, usability of the video contacts), the effectiveness (clinical ratings) and the tolerability of this treatment.

Official Title
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GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)

Conditions
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Depression

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: depressive episode according to ICD-10 moderate depression according to clinical impression or Hamilton depression rating scale gender: all sexes age: 18-70 years stable medication if possible no or stable treatment of depression residence in Germany and mother language German written informed consent Exclusion Criteria: contraindications for transcranial direct current stimulation neurological conditions participiation in another study pregnancy and lactation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prefrontal tDCS at home<br>trancranial direct current stimulation 30 sessions within 6 weeks (treatment on working days) 2mA with cathode on the right and anode an the left side | Device: tDCS<br>* trancranial direct current stimulation 30 sessions within 6 weeks (treatment on working days) 2mA with cathode on the right and anode an the left side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability for the patients | Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better] and open feedback | 6 weeks | 
| Usability for the handlers/clinicians | Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better] and open feedback | 6 weeks | 
| Compliance 1 (Number of days out of 30 the patients used the device) | Number of days out of 30 the patients used the device | 6 weeks | 
| Compliance 2 (Number of patients who completed the treatment regulary) | Number of patients who completed the treatment regulary | 6 weeks | 
| Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis) | Number of responders according the the clinical global impression change score for patients in the per protocol analysis | 6 weeks | 
| Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)) | Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items) | 6 weeks | 
| Stability of effects 1 (Number of responders according the the clinical global impression change score) | Number of responders according the the clinical global impression change score | 18 weeks | 
| Stability of effects 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)) | Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items) | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton depression rating scale | Depression rating scale (0-65, the lower the better) | 18 weeks | 
| Major Depression Inventory | Depression inventory (0-50, the lower the better) | 18 weeks | 
| WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF) | Quality of life scale inventory (4-20, the higher the better) | 18 weeks | 
| Clincial Global Impression change | Clincial Global Impression (1-7, the lower the better) | 18 weeks | 
| Pittsburgh sleep quality index | sleep inventory (0-21, the lower the better) | 18 weeks | 
| Depression anxiety stress scale (DASS) | Depression, anxiety and stress inventory (each 0-21, the lower the better) | 18 weeks | 
| Personality styles and disorder inventory | Depedence of treatment effect from personality as measured with the Personality styles and disorder inventory (PSDI) (T-value norms, values around 50 are normal) | 18 weeks |