- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444242
Accelerated Treatment of Depressive Patients With tDCS (AcctDCS)
Accelerated Treatment of Depressive Patients With tDCS (Twice Per Day) - a Placebo Controlled Home-based Treatment
A randomized, controlled three-arm study is planned to investigate the effectiveness and feasibility of an accelerated home-based tDCS application (3 weeks of transcranial direct current stimulation at home, twice daily). A total of 30 patients with depression (10 per group), who are currently not taking and have no history of taking antidepressant medication, will be randomly assigned to either an active tDCS condition, a sham (placebo) tDCS condition, or a waitlist control group. The latter two groups will receive active tDCS treatment after completion of the control phase.
This study represents a continuation of the pilot study GSUND DAHOAM (Ethics approval: 20-2091-101; Dragon et al., 2024).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate the feasibility of home-based tDCS for the accelerated treatment (twice daily) of depressive disorders (GSUND DAHOAM 2.0 = continuation of the study "GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise zur Medbo"; Dragon et al., 2024).
Specifically, the study will assess feasibility (device usability, patient compliance, and usability of the video consultation), effectiveness (clinical ratings), and tolerability of this intervention in 30 patients with depression. Participants will be randomly assigned to one of three groups: active tDCS treatment, sham (placebo) tDCS treatment, or a waitlist control group (waiting period: 3 weeks). The latter two groups will subsequently receive active tDCS treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Schoisswohl, PD, PhD
- Phone Number: +499419411284
- Email: stefan.schoisswohl@ukr.de
Study Contact Backup
- Name: Ulrike Stadler
- Phone Number: +499419411256
- Email: tms-psy-r@medbo.de
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sex: female, male, non-binary
- Age: 18-70 years
- Diagnosis of depression: no current or past psychiatric medication (current episode and history)
- Provision of informed consent to participate
- Sufficient proficiency in the German language
Exclusion Criteria:
- Presence of contraindications for tDCS (e.g., electrical implants or metallic objects in the body such as a cardiac pacemaker or insulin pump, dermatological conditions affecting the scalp)
- Neurological disorders (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformations, or a history of severe head injury)
- Participation in another clinical trial on depression within the 3 months prior to treatment initiation
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Verum accelerated home-based tDCS
10 patients will receive active tDCS during a three-week intervention (accelerated: twice daily).
|
Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), have gained increasing attention in recent years in both research and the treatment of various psychiatric disorders (Alonzo et al., 2019; Lefaucher et al., 2017). Compared to other neuromodulation methods, such as transcranial magnetic stimulation (TMS), tDCS offers the advantage of mobile or outpatient use, including home-based application. tDCS devices are small, portable, and cost-effective, and they are associated with a favorable side-effect profile (Alonzo et al., 2019).
Other Names:
|
|
Placebo Comparator: Sham accelerated home-based tDCS
10 patients will receive sham tDCS during a three-week intervention (accelerated: twice daily) with the opportunity to get active tDCS after study completion.
|
Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), have gained increasing attention in recent years in both research and the treatment of various psychiatric disorders (Alonzo et al., 2019; Lefaucher et al., 2017). Compared to other neuromodulation methods, such as transcranial magnetic stimulation (TMS), tDCS offers the advantage of mobile or outpatient use, including home-based application. tDCS devices are small, portable, and cost-effective, and they are associated with a favorable side-effect profile (Alonzo et al., 2019).
Other Names:
|
|
No Intervention: Waiting list
10 patients will have to wait for three weeks before the beginning ot the active tDCS intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Course of the scores of the Hamilton Depression rating scale (21 Items)
Time Frame: 3 weeks
|
Depression rating scale (0-65, the lower the better)
|
3 weeks
|
|
Course of the scores of the Major Depression Inventory
Time Frame: 3 weeks
|
Depression rating scale (0-50, the lower the better)
|
3 weeks
|
|
Compliance
Time Frame: 3 weeks
|
Number of treatments administered (0-30 sessions, the more the better)
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berthold Langguth, Prof, PhD, University of Regensburg
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Behavioral Symptoms
- Mood Disorders
- Depressive Disorder
- Behavior
- Depression
- Depressive Disorder, Major
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- 25-4450-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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