DepressionGSUND_DAHOAMNCT05123872
Transcranial Direct Current Stimulation as Home Treatment in Depression
A study testing tDCS in people with Depression, run by University of Regensburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contraindications for transcranial direct current stimulation
- neurological conditions
- participiation in another study
- pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- tDCS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| prefrontal tDCS at home | Experimental | 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 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 weeks
Compliance 2 (Number of patients who completed the treatment regulary)
Number of patients who completed the treatment regulary
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 18 weeks
Secondary outcomes (7)
Hamilton depression rating scale
Depression rating scale (0-65, the lower the better)
Measured: 18 weeks
Major Depression Inventory
Depression inventory (0-50, the lower the better)
Measured: 18 weeks
WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Measured: 18 weeks
Clincial Global Impression change
Clincial Global Impression (1-7, the lower the better)
Measured: 18 weeks
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
Measured: 18 weeks
Depression anxiety stress scale (DASS)
Depression, anxiety and stress inventory (each 0-21, the lower the better)
Measured: 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)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- neurocare group AG
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, PhD, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123872
- Sponsor's protocol ID
- 20-2091-101
- Acronym
- GSUND_DAHOAM
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)
- ClinicalTrials.gov ID
- NCT05123872
- Acronym / sponsor ID
- GSUND_DAHOAM / 20-2091-101
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- neurocare group AG
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prefrontal tDCS at home | Experimental | Device: tDCStrancranial direct current stimulation 30 sessions within 6 weeks (treatment on working days) 2mA with cathode on the right and anode an the left side |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- contraindications for transcranial direct current stimulation
- neurological conditions
- participiation in another study
- pregnancy and lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCStrancranial 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 | prefrontal tDCS at home |
Primary outcome
Usability for the patients
Time frame: 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
Usability for the handlers/clinicians
Time frame: 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)
Time frame: 6 weeks
Number of days out of 30 the patients used the device
Compliance 2 (Number of patients who completed the treatment regulary)
Time frame: 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)
Time frame: 6 weeks
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Efficiancy 2 (Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items))
Time frame: 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)
Time frame: 18 weeks
Number of responders according the the clinical global impression change score
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))
Time frame: 18 weeks
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
7 secondary outcomes
Hamilton depression rating scale
Time frame: 18 weeks
Major Depression Inventory
Time frame: 18 weeks
WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Time frame: 18 weeks
Clincial Global Impression change
Time frame: 18 weeks
Pittsburgh sleep quality index
Time frame: 18 weeks
Depression anxiety stress scale (DASS)
Time frame: 18 weeks
Personality styles and disorder inventory
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, PhD principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Depression, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability for the patients (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.