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ADHDNCT06766214

Attexis and tDCS for the Treatment of ADHD

A study testing transcranial direct current stimulation in people with ADHD, run by University of Regensburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
ADHD
What is being tested?
transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteGermany
Study dates
1 Sep 2024to 24 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Regensburg, Bavaria, 93053

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
ADHD
Being tested
transcranial direct current stimulation, sham transcranial direct current stimulation
Keywords
ADHD, tDCS, Attexis, Psychotherapy, Home-based
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial direct current stimulationDevice

    Also called attexis

    Simultaneous treatment with tDCS and online-based psychotherapy

  • sham transcranial direct current stimulationDevice

    Also called attexis

    Simultaneous treatment with sham-tDCS and online-based psychotherapy

Study groups in NCT06766214
Study groupRoleWhat they receive
Attexis and tDCSExperimental15 patients receive three-month access to the psychotherapy app attexis and a tDCS device from the company Sooma, which is set to verum
Receives: Device: transcranial direct current stimulation
Attexis and placebo-tDCSPlacebo comparator15 patients receive three-month access to the psychotherapy app attexis and a tDCS device from the company Sooma, which is set to sham
Receives: Device: sham transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance (Number of days (60) of actual (Placebo-)tDCS-treatment)

    Number of days of treatment with (Placebo-)tDCS

    Measured: 12 weeks

  2. Efficacy 1 (Number of responders according to the ASRS-v1.1)

    (Number of responders according to the ASRS-v1.1)

    Measured: 12 weeks

  3. Efficacy 2 (Number of responders according to the subscale attention of the ASRS-v1.1)

    Number of responders according to the subscale attention of the ASRS-v1.1

    Measured: 12 weeks

  4. Efficacy 3 (Number of responders according to the subscale hyperactivity of the ASRS-v1.1)

    Number of responders according to the subscale hyperactivity of the ASRS-v1.1

    Measured: 12 weeks

  5. Stability of effects (Number of responders according to the change of the final ASRS-v1.1 sumscore)

    Number of responders according to the change of the ASRS-v1.1 sumscore after treatment

    Measured: 24 weeks

Secondary outcomes (4)

  1. Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, sumscore)

    Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (sumscore: 0-72)

    Measured: 12 weeks

  2. Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: Attention)

    Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (subscale A: 0-36)

    Measured: 12 weeks

  3. Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1, Subscale: hyperactivity)

    Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1) (the less the better) (subscale B: 0-36)

    Measured: 12 weeks

  4. Usability (sumscore of the Usability experience questionnaire UEQ)

    Sumscore of the usability experience questionnaire

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Sep 2024
  3. Primary completion21 Nov 2025
  4. Study completion24 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1\. treatment with Attexis and tDCS and 2. treatment with Attexis and placebo tDCS
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766214
Sponsor's protocol ID
24-3862-101
Status last verified
Feb 2026
First submitted
22 Nov 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with ADHD, run by University of Regensburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance (Number of days (60) of actual (Placebo-)tDCS-treatment) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06766214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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