Transcranial Direct Current Stimulation as Home Treatment in Depression

Depression Clinical Trial

— GSUND_DAHOAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05123872
• Other study ID #: 20-2091-101
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2023
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Regensburg	neurocare group AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Compliance 2 (Number of patients who completed the treatment regulary)	Number of patients who completed the treatment regulary	6 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Hamilton depression rating scale	Depression rating scale (0-65, the lower the better)	18 weeks
Secondary	Major Depression Inventory	Depression inventory (0-50, the lower the better)	18 weeks
Secondary	WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)	Quality of life scale inventory (4-20, the higher the better)	18 weeks
Secondary	Clincial Global Impression change	Clincial Global Impression (1-7, the lower the better)	18 weeks
Secondary	Pittsburgh sleep quality index	sleep inventory (0-21, the lower the better)	18 weeks
Secondary	Depression anxiety stress scale (DASS)	Depression, anxiety and stress inventory (each 0-21, the lower the better)	18 weeks
Secondary	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