An interventional study of Transcranial Direct Current Stimulation - Active and Transcranial Direct Current Stimulation - Sham in Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 25 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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.
Device: Transcranial Direct Current Stimulation - Active · Behavioral: 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.
Device: Transcranial Direct Current Stimulation - Sham · Behavioral: Cognitive Training
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.
The sham condition mimics the active setup but delivers only brief ramp-up/down stimulation, producing the initial sensation without sustained current.
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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Time frame: Throughout the 10-day intervention period and at follow-up (up to 2 weeks post-intervention)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute