An interventional study of tDCS in Depression, sponsored by University of Regensburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment
In this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 10 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Compliance 2 (Number of patients who completed the treatment regulary)
Number of patients who completed the treatment regulary
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 18 weeks
Hamilton depression rating scale
Depression rating scale (0-65, the lower the better)
Time frame: 18 weeks
Major Depression Inventory
Depression inventory (0-50, the lower the better)
Time frame: 18 weeks
WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Time frame: 18 weeks
Clincial Global Impression change
Clincial Global Impression (1-7, the lower the better)
Time frame: 18 weeks
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
Time frame: 18 weeks
Depression anxiety stress scale (DASS)
Depression, anxiety and stress inventory (each 0-21, the lower the better)
Time frame: 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)
Time frame: 18 weeks
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Regensburg