Attexis and tDCS for the Treatment of ADHD

February 24, 2026 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Augmentation Von Online-Psychotherapie Mit tDCS Bei Der Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS)

A randomized controlled two-arm study (RCT) will be conducted. It is planned to randomly assign eligible patients who receive a three-month access to the psychotherapeutic program (Attexis) to either an additional verum-tDCS or placebo-tDCS condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine whether the effectiveness of the home-based therapy program "Attexis" can be augmented with another home-based procedure, tDCS treatment, in order to achieve even higher improvement rates in the treatment of ADHD in the future. Before the actual start of treatment with Attexis, the presence of an ADHD diagnosis (ICD-10: F90.0) is checked by qualified medical staff at Medbo Regensburg. If the screened patient then meets the other inclusion criteria for Attexis and tDCS, he or she will be randomly assigned to either the intervention group (receives access to both Attexis and tDCS) or the placebo group (receives access to both Attexis and placebo tDCS). Based on the study by Schlechter et al. (2023), it is planned to treat patients receiving (placebo) tDCS treatment with 60 sessions (2mA, 20 minutes per day) by stimulating the left DLPFC. As patients will have a three-month access to Attexis, it is planned to administer the additional (placebo) tDCS treatment at the same time. As soon as a patient registers for the study, the safety aspects and inclusion/exclusion criteria for tDCS treatment are also checked in an initial interview after the ADHD diagnosis has been verified. The patient is then randomly assigned to one of the two study arms. A suitable appointment is then arranged for the patient to be admitted to the device. About 60 minutes are scheduled for the explanation and instruction of the tDCS device. During the appointment, an initial trial treatment is carried out so that the patient can get used to the treatment. All subsequent home-based treatments are carried out from Monday to Friday (each lasting 20 minutes) with video observation during the first week of treatment. For the sessions via teletherapy, software approved for clinical use (CLICKDOC version 5.9.1, La-Well Systems GmbH, CompuGroup Medical SE & Co. KGaA, Bünde, Germany) is to be used. At the end of the tDCS treatment, a final consultation will be arranged, which will take about 45 minutes. A follow-up (clinical ratings and attention test) will be carried out after 3 months.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gender: female, male, non-binary
  • Age: 18 - 65
  • Diagnosis of ADHD according to ICD-10
  • ADHD severity score (cut-off): Score of ≥17 on either the inattention subscale or the impulsivity/hyperactivity subscale of the ASRS v1.1
  • Stable treatment (psychotherapy, medication, no treatment, ...) (if applicable) for at least 30 days at the time of admission
  • Consent to participate
  • Sufficient knowledge of the German language

Exclusion Criteria:

tDCS:

  • Fulfillment of the contraindications for tDCS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps, skin diseases on the head)
  • Neurological diseases (e.g. cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformation, history of severe head injuries)
  • Participation in another study during treatment
  • Pregnancy or breastfeeding

Attexis:

  • Diagnosis of a comorbid clinically relevant severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)
  • Plan to change an ongoing treatment (psychotherapy, medication, ...) in the next three months after enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Attexis and tDCS
15 patients receive three-month access to the psychotherapy app attexis and a tDCS device from the company Sooma, which is set to verum
Device: transcranial direct current stimulation
Simultaneous treatment with tDCS and online-based psychotherapy
Other Names:
  • attexis
Placebo Comparator: Attexis and placebo-tDCS
15 patients receive three-month access to the psychotherapy app attexis and a tDCS device from the company Sooma, which is set to sham
Device: sham transcranial direct current stimulation
Simultaneous treatment with sham-tDCS and online-based psychotherapy
Other Names:
  • attexis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance (Number of days (60) of actual (Placebo-)tDCS-treatment)
Time Frame: 12 weeks
Number of days of treatment with (Placebo-)tDCS
12 weeks
Efficacy 1 (Number of responders according to the ASRS-v1.1)
Time Frame: 12 weeks
(Number of responders according to the ASRS-v1.1)
12 weeks
Efficacy 2 (Number of responders according to the subscale attention of the ASRS-v1.1)
Time Frame: 12 weeks
Number of responders according to the subscale attention of the ASRS-v1.1
12 weeks
Efficacy 3 (Number of responders according to the subscale hyperactivity of the ASRS-v1.1)
Time Frame: 12 weeks
Number of responders according to the subscale hyperactivity of the ASRS-v1.1
12 weeks
Stability of effects (Number of responders according to the change of the final ASRS-v1.1 sumscore)
Time Frame: 24 weeks
Number of responders according to the change of the ASRS-v1.1 sumscore after treatment
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, sumscore)
Time Frame: 12 weeks
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (sumscore: 0-72)
12 weeks
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: Attention)
Time Frame: 12 weeks
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (subscale A: 0-36)
12 weeks
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: hyperactivity)
Time Frame: 12 weeks
Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (subscale B: 0-36)
12 weeks
Usability (sumscore of the Usability experience questionnaire UEQ)
Time Frame: 12 weeks
Sumscore of the usability experience questionnaire
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Collaborators

Gaia AG
Sooma Medical

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

November 21, 2025

Study Completion (Actual)

February 24, 2026

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-3862-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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