Autism Spectrum DisorderNCT06946433
tDCS in Adults With ASD and/or ADHD Without Intellectual Disability
A study testing Transcranial Direct Current Stimulation - Active and Cognitive Training in people with Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Transcranial Direct Current Stimulation - Active and Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ensayo clínico Fase 1 de tDCS en Adultos Con TEA y/o TDAH Sin Discapacidad Intelectual
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:
Read more
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
- Being tested
- Transcranial Direct Current Stimulation - Active, Transcranial Direct Current Stimulation - Sham, Cognitive Training
- Keywords
- tdcs, autism, adhd
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation - ActiveDevice
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.
Transcranial Direct Current Stimulation - ShamDevice
The sham condition mimics the active setup but delivers only brief ramp-up/down stimulation, producing the initial sensation without sustained current.
Cognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Cognitive Training | Active comparator | 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. Receives: Device: Transcranial Direct Current Stimulation - Active; Behavioral: Cognitive Training |
| Sham tDCS + Cognitive Training | Sham comparator | 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. Receives: Device: Transcranial Direct Current Stimulation - Sham; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the 10-day intervention period and at follow-up (up to 2 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start7 Nov 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946433
- Sponsor's protocol ID
- PR (AG) 218_2022
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo clínico Fase 1 de tDCS en Adultos Con TEA y/o TDAH Sin Discapacidad Intelectual
- ClinicalTrials.gov ID
- NCT06946433
- Acronym / sponsor ID
- PR (AG) 218_2022
- Keywords
- tdcs, autism, adhd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Cognitive Training | Active comparator | Device: Transcranial Direct Current Stimulation - Active, Behavioral: Cognitive TrainingParticipants 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. |
| Sham tDCS + Cognitive Training | Sham comparator | Device: Transcranial Direct Current Stimulation - Sham, Behavioral: Cognitive TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation - ActiveThis 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. | Device | Active tDCS + Cognitive Training |
| Transcranial Direct Current Stimulation - ShamThe sham condition mimics the active setup but delivers only brief ramp-up/down stimulation, producing the initial sensation without sustained current. | Device | Sham tDCS + Cognitive Training |
| Cognitive TrainingThe 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. | Behavioural | Active tDCS + Cognitive Training, Sham tDCS + Cognitive Training |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation - Active and Cognitive Training in people with Autism Spectrum Disorder and Attention Deficit Disorder With Hyperactivity, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Throughout the 10-day intervention period and at follow-up (up to 2 weeks post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.