Attexis and tDCS for the Treatment of ADHD

NCT06766214 | Completed

• 1 other identifier: 24-3862-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Keywords

ADHD; tDCS; Attexis; Psychotherapy; Home-based

Outcome Measures

Primary Outcomes (5)

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

  Number of days of treatment with (Placebo-)tDCS

  12 weeks

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

  (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)

  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)

  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)

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

  24 weeks

Secondary Outcomes (4)

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

  12 weeks

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

  12 weeks

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

  12 weeks

• Usability (sumscore of the Usability experience questionnaire UEQ)

  12 weeks

Study Arms (2)

Attexis and tDCS

EXPERIMENTAL

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

Attexis and placebo-tDCS

PLACEBO COMPARATOR

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

Interventions

sham transcranial direct current stimulation DEVICE

Simultaneous treatment with sham-tDCS and online-based psychotherapy

Also known as: attexis

Attexis and placebo-tDCS

transcranial direct current stimulation DEVICE

Simultaneous treatment with tDCS and online-based psychotherapy

Also known as: attexis

Attexis and tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead
• Sooma Medical: collaborator
• Gaia AG: collaborator

Study Sites (1)

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

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Berthold Langguth, PhD

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: https://www.random.org/lists/
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD, PhD

Model Details: 1\. treatment with Attexis and tDCS and 2. treatment with Attexis and placebo tDCS

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: January 9, 2025
• Study Start: September 1, 2024
• Primary Completion: November 21, 2025
• Study Completion: February 24, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

DE (1)