GSUND_DAHOAM: Transcranial Direct Current Stimulation as Home Treatment in Depression

Sponsor
University of Regensburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05123872
Collaborator
neurocare group AG (Other)
10
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: tDCS
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise Zur Medbo (Transcranial Direct Current Stimulation and Depression: Home Treatment)
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. Compliance 1 [6 weeks]

    Number of days out of 30 the patients used the device

  4. Compliance 2 [6 weeks]

    Number of patients who completed the treatment regulary

  5. Efficiancy 1 [6 weeks]

    Number of responders according the the clinical global impression change score for patients in the per protocol analysis

  6. Efficiancy 2 [6 weeks]

    Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

  7. Stability of effects 1 [18 weeks]

    Number of responders according the the clinical global impression change score

  8. Stability of effects 2 [18 weeks]

    Eeffect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

Secondary Outcome Measures

  1. Hamilton depression rating scale [18 weeks]

    Depression rating scale (0-65, the lower the better)

  2. Major Depression Inventory [18 weeks]

    Depression inventory (0-50, the lower the better)

  3. WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF) [18 weeks]

    Quality of life scale inventory (4-20, the higher the better)

  4. Clincial Global Impression change [18 weeks]

    Clincial Global Impression (1-7, the lower the better)

  5. Pittsburgh sleep quality index [18 weeks]

    sleep inventory (0-21, the lower the better)

  6. Depression anxiety stress scale (DASS) [18 weeks]

    Depression, anxiety and stress inventory (each 0-21, the lower the better)

  7. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of Psychiatry and Psychotherapy, University of RegensburgRegensburgGermany93055

Sponsors and Collaborators

  • University of Regensburg
  • neurocare group AG

Investigators

  • Principal Investigator: Berthold Langguth, PhD, University of Regensburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Berthold Langguth, MD, Ph.D., Clinical Professor, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT05123872
Other Study ID Numbers:
  • 20-2091-101
First Posted:
Nov 17, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021