tDCS in Adults With ASD and/or ADHD Without Intellectual Disability

NCT ID: NCT06946433

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2024-01-19

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

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS + Cognitive Training

Participants in this arm will receive anodal transcranial direct current stimulation (tDCS) at 2 mA for 20 minutes per session over 10 consecutive workdays. The anode will be placed over the left dorsolateral prefrontal cortex (F3) and the cathode over the right frontopolar cortex (Fp2) using the 10-20 EEG system. Stimulation will be administered concurrently with cognitive training using the NeuronUP platform, which includes tasks targeting attention, memory, and executive function.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation - Active

Intervention Type: DEVICE

This intervention involves non-invasive brain stimulation using transcranial direct current stimulation (tDCS) delivered via saline-soaked sponge electrodes. The anode is placed at F3 (left dorsolateral prefrontal cortex) and the cathode at Fp2 (right frontopolar cortex), according to the international 10-20 EEG system. A 2 mA current is applied for 20 minutes per session, administered once daily on 10 consecutive workdays.

During stimulation, participants engage in cognitive training using the NeuronUP platform, which provides structured, interactive tasks designed to train executive function, attention, and working memory. This combination aims to enhance neural plasticity by pairing neuromodulation with cognitive engagement.

Cognitive Training

Intervention Type: BEHAVIORAL

The cognitive training intervention in this study is delivered through NeuronUP, a digital platform offering evidence-based cognitive stimulation activities. This intervention targets core cognitive domains such as working memory, attention, and executive function through personalized, interactive tasks. What distinguishes this approach is NeuronUP's extensive library of over 10,000 activities, its ability to tailor difficulty levels in real time based on individual performance, and the inclusion of functional tasks that mirror real-life scenarios. Unlike other interventions, NeuronUP also enables therapist-guided customization, allowing for individualized treatment plans that evolve with participant progress, ensuring both relevance and ecological validity.

Sham tDCS + Cognitive Training

Participants in this arm will undergo the same setup and procedures as the active tDCS group but will receive sham stimulation, which mimics the sensation of tDCS without delivering current beyond the initial ramp-up/down. They will also complete cognitive training with the NeuronUP platform during each session.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation - Sham

Intervention Type: DEVICE

The sham condition mimics the active setup but delivers only brief ramp-up/down stimulation, producing the initial sensation without sustained current.

Cognitive Training

Intervention Type: BEHAVIORAL

The cognitive training intervention in this study is delivered through NeuronUP, a digital platform offering evidence-based cognitive stimulation activities. This intervention targets core cognitive domains such as working memory, attention, and executive function through personalized, interactive tasks. What distinguishes this approach is NeuronUP's extensive library of over 10,000 activities, its ability to tailor difficulty levels in real time based on individual performance, and the inclusion of functional tasks that mirror real-life scenarios. Unlike other interventions, NeuronUP also enables therapist-guided customization, allowing for individualized treatment plans that evolve with participant progress, ensuring both relevance and ecological validity.

Interventions

Transcranial Direct Current Stimulation - Active

This intervention involves non-invasive brain stimulation using transcranial direct current stimulation (tDCS) delivered via saline-soaked sponge electrodes. The anode is placed at F3 (left dorsolateral prefrontal cortex) and the cathode at Fp2 (right frontopolar cortex), according to the international 10-20 EEG system. A 2 mA current is applied for 20 minutes per session, administered once daily on 10 consecutive workdays.

During stimulation, participants engage in cognitive training using the NeuronUP platform, which provides structured, interactive tasks designed to train executive function, attention, and working memory. This combination aims to enhance neural plasticity by pairing neuromodulation with cognitive engagement.

Intervention Type: DEVICE

Transcranial Direct Current Stimulation - Sham

The sham condition mimics the active setup but delivers only brief ramp-up/down stimulation, producing the initial sensation without sustained current.

Intervention Type: DEVICE

Cognitive Training

The cognitive training intervention in this study is delivered through NeuronUP, a digital platform offering evidence-based cognitive stimulation activities. This intervention targets core cognitive domains such as working memory, attention, and executive function through personalized, interactive tasks. What distinguishes this approach is NeuronUP's extensive library of over 10,000 activities, its ability to tailor difficulty levels in real time based on individual performance, and the inclusion of functional tasks that mirror real-life scenarios. Unlike other interventions, NeuronUP also enables therapist-guided customization, allowing for individualized treatment plans that evolve with participant progress, ensuring both relevance and ecological validity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

PR (AG) 218_2022

Identifier Type: -

Identifier Source: org_study_id