Attention Deficit Disorder With HyperactivityNCT06974136
tES Modalities for the Treatment of ADHD
A study testing transcranial electrical stimulation in people with Attention Deficit Disorder With Hyperactivity and Neurodevelopmental Disorders, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Neurodevelopmental Disorders
- What is being tested?
- transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- 30 Mar 2025to 1 May 2026
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist
- being 7-18 years old
- providing written informed consent signed by parents
Who cannot join
- comorbidity with other neurodevelopmental disorders
- Comorbidity with other neurological disorders
- previous history of neurosurgery
- Presence of any ferromagnetic metal in the head
- implanted medical devices in the head or neck region
- history of non-controlled epilepsy with seizures in the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder
This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.
Read the detailed description
This project aims to evaluate the therapeutic potential of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), as innovative, non-invasive interventions for managing Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. ADHD is a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impair daily functioning. Conventional treatments, such as pharmacological interventions and behavioral therapies, may have limitations, including side effects or variable efficacy, prompting the exploration of neuromodulation techniques like tES.
- Being tested
- transcranial electrical stimulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulationDevice
Also called tDCS, tACS
Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique that applies low-intensity electrical currents to the scalp to modulate brain activity. It targets specific brain regions to influence neuronal excitability, connectivity, and plasticity, offering potential therapeutic benefits for neurological and psychiatric conditions. tES is portable, cost-effective, and generally well-tolerated, with minimal side effects such as mild tingling or itching at the stimulation site.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS group | Active comparator | This group receives Transcranial Direct Current Stimulation (tDCS). tDCS delivers a constant, low-intensity direct current (typically 1-2 mA) through electrodes placed on the scalp. The anode (positive electrode) increases cortical excitability by depolarizing neurons, while the cathode (negative electrode) decreases excitability by hyperpolarizing neurons. Receives: Device: transcranial electrical stimulation |
| active tACS group | Active comparator | This group receives Transcranial Alternating Current Stimulation (tACS). tACS applies an oscillating current at specific frequencies (e.g., 1-100 Hz) to entrain or synchronize neural oscillations. By aligning the stimulation frequency with endogenous brain rhythms (e.g., theta or gamma bands), tACS can modulate network dynamics, potentially normalizing aberrant oscillatory patterns associated with disorders like ADHD. Receives: Device: transcranial electrical stimulation |
| sham group | Placebo comparator | This group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation Receives: Device: transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms- Clinical rating scale
ADHD symptoms will be assessed using a DSM-based structured interview. This approach involves a systematic, standardized method to evaluate the presence and severity of ADHD symptoms based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), likely the DSM-5, which is widely used for diagnosing ADHD.
Measured: Baseline, week 2, up to 1 month after the intervention
Secondary outcomes (3)
Executive function- Performance accuracy and reaction time
Performance in an executive functions computerized task
Measured: Baseline, week 2, up to 1 month after the intervention
electroencephalogram (EEG) power
Change in the EEG alpha/theta/gamma power
Measured: Baseline, week 2
electroencephalogram (EEG) functional connectivity
Measured: Baseline, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start30 Mar 2025
- Primary completion1 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University, Institute for Research in Fundamental Sciences (IPM)
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974136
- Sponsor's protocol ID
- IPM-NDD
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder
- ClinicalTrials.gov ID
- NCT06974136
- Acronym / sponsor ID
- IPM-NDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- RWTH Aachen University, Institute for Research in Fundamental Sciences (IPM)
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 May 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.
This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.
Detailed description
This project aims to evaluate the therapeutic potential of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), as innovative, non-invasive interventions for managing Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. ADHD is a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impair daily functioning. Conventional treatments, such as pharmacological interventions and behavioral therapies, may have limitations, including side effects or variable efficacy, prompting the exploration of neuromodulation techniques like tES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active tDCS group | Active comparator | Device: transcranial electrical stimulationThis group receives Transcranial Direct Current Stimulation (tDCS). tDCS delivers a constant, low-intensity direct current (typically 1-2 mA) through electrodes placed on the scalp. The anode (positive electrode) increases cortical excitability by depolarizing neurons, while the cathode (negative electrode) decreases excitability by hyperpolarizing neurons. |
| active tACS group | Active comparator | Device: transcranial electrical stimulationThis group receives Transcranial Alternating Current Stimulation (tACS). tACS applies an oscillating current at specific frequencies (e.g., 1-100 Hz) to entrain or synchronize neural oscillations. By aligning the stimulation frequency with endogenous brain rhythms (e.g., theta or gamma bands), tACS can modulate network dynamics, potentially normalizing aberrant oscillatory patterns associated with disorders like ADHD. |
| sham group | Placebo comparator | Device: transcranial electrical stimulationThis group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist
- being 7-18 years old
- providing written informed consent signed by parents
Key exclusion criteria (6 listed)
- comorbidity with other neurodevelopmental disorders
- Comorbidity with other neurological disorders
- previous history of neurosurgery
- Presence of any ferromagnetic metal in the head
- implanted medical devices in the head or neck region
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 electrical stimulationAlso: tDCS, tACSTranscranial electrical stimulation (tES) is a non-invasive neuromodulation technique that applies low-intensity electrical currents to the scalp to modulate brain activity. It targets specific brain regions to influence neuronal excitability, connectivity, and plasticity, offering potential therapeutic benefits for neurological and psychiatric conditions. tES is portable, cost-effective, and generally well-tolerated, with minimal side effects such as mild tingling or itching at the stimulation site. | Device | active tACS group, active tDCS group, sham group |
Primary outcome
ADHD symptoms- Clinical rating scale
Time frame: Baseline, week 2, up to 1 month after the intervention
ADHD symptoms will be assessed using a DSM-based structured interview. This approach involves a systematic, standardized method to evaluate the presence and severity of ADHD symptoms based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), likely the DSM-5, which is widely used for diagnosing ADHD.
3 secondary outcomes
Executive function- Performance accuracy and reaction time
Time frame: Baseline, week 2, up to 1 month after the intervention
electroencephalogram (EEG) power
Time frame: Baseline, week 2
electroencephalogram (EEG) functional connectivity
Time frame: Baseline, week 2
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 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
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 electrical stimulation in people with Attention Deficit Disorder With Hyperactivity and Neurodevelopmental Disorders, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
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 3 inclusion and 6 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 4 Aug 2026. 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 Iran. 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?
ADHD symptoms- Clinical rating scale (time frame: Baseline, week 2, up to 1 month after the 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 4 Aug 2026.