Transcranial Direct Current Stimulation as Home Treatment in Depression (GSUND_DAHOAM)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Device: tDCS

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93055
    • Department of Psychiatry and Psychotherapy, University of Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: prefrontal tDCS at home; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Regensburg
• Collaborators: neurocare group AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (ACTUAL): November 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 20-2091-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No