Transcranial Direct Current Stimulation as Home Treatment in Depression

Not Applicable

Active, not recruiting

• Conditions: Depression
• Interventions: Device: tDCS

• Registration Number: NCT05123872
• Lead Sponsor: University of Regensburg

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-09-21
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-17
• Primary Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• contraindications for transcranial direct current stimulation
• neurological conditions
• participiation in another study
• pregnancy and lactation period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prefrontal tDCS at home	tDCS	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

Primary Outcome Measures

Name	Time	Method
Usability for the handlers/clinicians	6 weeks	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
Compliance 1 (Number of days out of 30 the patients used the device)	6 weeks	Number of days out of 30 the patients used the device
Usability for the patients	6 weeks	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
Compliance 2 (Number of patients who completed the treatment regulary)	6 weeks	Number of patients who completed the treatment regulary
Efficiancy 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis)	6 weeks	Number of responders according the the clinical global impression change score for patients in the per protocol analysis
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))	18 weeks	Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))	6 weeks	Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Stability of effects 1 (Number of responders according the the clinical global impression change score)	18 weeks	Number of responders according the the clinical global impression change score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg; 🇩🇪 Regensburg, Germany