Transcranial Direct Current Stimulation as Home Treatment in Depression

NCT ID: NCT05123872

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-04-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

neurocare group AG

UNKNOWN

Sponsor Role: collaborator

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

Clinical Professor, MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, , Germany

Countries

Germany

Other Identifiers

20-2091-101

Identifier Type: -

Identifier Source: org_study_id