Phase 1 RCT of tDCS in Adults With ASD and/or ADHD Without Intellectual Disability

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Attention Deficit Disorder With Hyperactivity

• Registration Number: NCT06946433
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The goal of this clinical trial is to learn about the safety and tolerability of transcranial direct current stimulation (tDCS) combined with cognitive training in adults with Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD).

The main question it aims to answer is:

Is tDCS safe and well-tolerated in adults with ASD and/or ADHD?

Researchers will compare active tDCS to a sham (placebo-like) stimulation to evaluate safety and tolerability.

Participants will:

Receive either active or sham tDCS for 20 minutes daily over 10 consecutive workdays

Undergo stimulation with the anode placed at F3 and the cathode at Fp2

Complete daily cognitive training exercises using the NeuronUP platform during stimulation

Attend baseline and follow-up assessments to monitor for any side effects or discomfort related to the intervention

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Adults aged 18 to 55 years

Clinical diagnosis of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) confirmed via medical records or structured clinical interview

Able to provide informed consent

Fluent in the language used for assessments and cognitive training tasks

Stable medication regimen (if applicable) for at least 4 weeks prior to enrollment

Willing and able to attend 10 consecutive weekday sessions and follow-up assessment

Exclusion Criteria

History of epilepsy, seizures, or significant neurological disorder (e.g., traumatic brain injury, stroke)

Current diagnosis of psychotic disorder or bipolar disorder

Presence of metal implants in the head (excluding dental work), pacemaker, or other contraindications to tDCS

Current substance use disorder (within past 6 months)

Pregnant or planning to become pregnant during the study period

Participation in another intervention study within the last 30 days

Any condition that, in the opinion of the investigators, may make participation unsafe or interfere with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Throughout the 10-day intervention period and at follow-up (up to 2 weeks post-intervention)	Participants will be monitored for adverse events, side effects (e.g., headache, skin irritation, fatigue), and dropout rates. This will be assessed through participant self-report, clinician observation, and standardized side effect checklists administered during and after each session. The outcome will help determine whether daily tDCS paired with cognitive training is safe and acceptable for adults with ASD and/or ADHD.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain