Using Attexis and tDCS to treat ADHD
Augmentation Von Online-Psychotherapie Mit tDCS Bei Der Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS)
This study is testing if a home therapy program called Attexis, combined with a brain stimulation treatment, can help adults with ADHD feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 1 site (Regensburg, Bavaria) |
| Trial ID | NCT06766214 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a home-based therapy program called Attexis, combined with transcranial direct current stimulation (tDCS), for treating adults with ADHD. Participants diagnosed with ADHD will be randomly assigned to receive either the Attexis program along with active tDCS or a placebo version of tDCS. The study will assess whether the addition of tDCS enhances the therapeutic effects of Attexis over a three-month period. Safety and eligibility will be confirmed through initial screenings before treatment begins.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a confirmed diagnosis of ADHD and a specific severity score.
Not a fit: Patients with severe comorbid psychiatric disorders or contraindications for tDCS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with ADHD.
How similar studies have performed: Previous studies have shown promise in using tDCS for ADHD, but this specific combination with Attexis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Regensburg, Bavaria
- Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany — Regensburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Berthold Langguth, PhD — University of Regensburg
- Study coordinator: Martin Schecklmann, PhD
- Email: martin.schecklmann@medbo.de
- Phone: 00499419412054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.