Attention-Deficit/Hyperactivity DisorderNCT07633275
Fronto-Parietal Transcranial Alternating Current Stimulation for ADHD in Children and Adolescents
A study testing Active transcranial alternating current stimulation in people with Attention-Deficit/Hyperactivity Disorder, run by Central South University at 1 site in China.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, inhibitory control, working memory, and other executive functions. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Active transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2026to 29 Jun 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 6-18 years, Han Chinese, and right-handed;
- Normal or corrected-to-normal vision and normal hearing;
- Meets the DSM-5 diagnostic criteria for attention-deficit/hyperactivity disorder, predominantly inattentive presentation;
- Meets the diagnostic threshold for inattention based on the parent-rated SNAP-IV scale;
- Performance on the symbol cancellation test, converted to a grade-standardized score, is below the average level;
- Has normal intelligence as confirmed by a brief intelligence assessment, with no significant emotional disorder or severe physical illness;
- Able to cooperate with electroencephalography recording and transcranial alternating current stimulation.
Who cannot join
- Meets diagnostic criteria for other major psychiatric disorders, such as schizophrenia or bipolar disorder;
- Has severe physical diseases, such as significant intracranial lesions, thyroid disease, epilepsy, congenital heart disease, severe hematological disease, systemic lupus erythematosus, or significant visual or hearing impairment;
- Has known obvious brain structural abnormalities based on available cranial imaging or medical history;
- Has severe neurological disease, a clear family history of hereditary neurological disorders, or other conditions associated with high neurological risk;
- Has metal implants or a cardiac pacemaker in the body, or has skull defects, holes, or fractures;
- Is currently receiving other pharmacological or behavioral treatment for ADHD, such as methylphenidate medication or behavioral intervention.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
About this study
Official title: Effects and Neural Mechanisms of Fronto-Parietal Transcranial Alternating Current Stimulation in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, inhibitory control, working memory, and other executive functions. The fronto-parietal brain network is thought to play an important role in these cognitive functions. Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that may influence brain activity. This study aims to evaluate whether 5-Hz tACS targeting the right frontal and parietal regions can improve executive functioning in children and adolescents aged 6 to 18 years with ADHD. The study also aims to explore whether any effects of tACS are related to changes in brain activity measured by electroencephalography (EEG). Participants will receive both active tACS and sham stimulation in a randomized, double-blind, crossover design. Clinical symptoms, executive function performance, and EEG measures will be assessed before and after each stimulation session. The main hypothesis is that active fronto-parietal tACS will produce greater improvement in executive functioning than sham stimulation, and that these effects may be associated with changes in EEG-measured brain activity.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Active transcranial alternating current stimulation, Sham transcranial alternating current stimulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial alternating current stimulationDevice
Active transcranial alternating current stimulation (tACS) will be delivered over the right frontoparietal region using a multi-electrode montage. Electrodes will be placed at F4, F2, AF4, and F6 over the right frontal region, and at P4, CP4, P6, and PO4 over the right parietal region. F4 and P4 will be configured as return electrodes according to the stimulation protocol. The stimulation will be applied as a 5-Hz sinusoidal alternating current with a total current intensity of 2 mA. Each stimulation session will last 12 minutes, including 60-second ramp-up and 60-second ramp-down periods.
Sham transcranial alternating current stimulationDevice
Sham transcranial alternating current stimulation will use the same electrode montage, device appearance, and setup procedures as active tACS. Electrodes will be placed at F4, F2, AF4, and F6 over the right frontal region, and at P4, CP4, P6, and PO4 over the right parietal region. F4 and P4 will be configured as return electrodes as in the active stimulation condition. The sham procedure will include brief ramp-up and ramp-down periods of approximately 60 seconds to mimic the sensory experience of active stimulation, with no sustained current delivered.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS followed by sham stimulation | Experimental | Participants randomized to this arm will receive active transcranial alternating current stimulation (tACS) first, followed by sham stimulation after a washout interval of at least 2 days. Both interventions will use the same right frontoparietal electrode montage. Receives: Device: Active transcranial alternating current stimulation; Device: Sham transcranial alternating current stimulation |
| Sham stimulation followed by active tACS | Experimental | Participants randomized to this arm will receive sham stimulation first, followed by active transcranial alternating current stimulation (tACS) after a washout interval of at least 2 days. Both interventions will use the same right frontoparietal electrode montage. Receives: Device: Active transcranial alternating current stimulation; Device: Sham transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention performance measured by the Test of Attentional Performance for Children
Attention performance will be assessed using the Test of Attentional Performance for Children, including seven child-adapted attention subtests covering alertness, distractibility, divided attention, cognitive flexibility, response inhibition, sustained attention, and visual scanning. Outcome indices include reaction time, reaction time variability, accuracy, omission errors, commission errors, and other task-specific performance measures. In general, shorter reaction time, lower reaction time variability, higher accuracy, and fewer errors indicate better attention performance.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in task-related EEG indices during the visual search task
Task-related electroencephalography will be recorded during a visual search task in which participants identify the direction of a visual target and respond using a joystick. EEG outcomes will include event-related potential measures, such as N2pc amplitude and latency, time-frequency measures across predefined frequency bands, and alpha-band channel tuning function indices reflecting spatially selective neural responses. These measures do not have a fixed clinical score range.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Secondary outcomes (8)
Change in ADHD symptoms measured by the SNAP-IV Parent Rating Scale
ADHD symptoms will be assessed using the parent-rated Swanson, Nolan, and Pelham-IV Rating Scale 26-item version (SNAP-IV). The scale includes items assessing inattention, hyperactivity/impulsivity, and oppositional symptoms. Each item is rated on a 4-point scale: 0 = not at all, 1 = just a little, 2 = quite a bit, and 3 = very much. Total score and subscale scores are calculated by summing or averaging the relevant items. Higher scores indicate more severe ADHD-related and oppositional symptoms.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in abnormal behaviors measured by the Aberrant Behavior Checklist-Second Edition
Behavioral abnormalities will be assessed using the Aberrant Behavior Checklist-Second Edition (ABC-II). The ABC-II evaluates the frequency and severity of behavioral problems. Each item is rated on a 4-point scale: 0 = not a problem, 1 = the behavior is a problem but slight in degree, 2 = the problem is moderately serious, and 3 = the problem is severe. The total score is calculated by summing all item scores. Higher scores indicate more severe and widespread behavioral problems.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in depressive symptoms measured by the Patient Health Questionnaire-9
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 includes 9 items assessing depressive symptoms during the past two weeks. Each item is rated on a 4-point scale: 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 scale
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7). The GAD-7 includes 7 items assessing the frequency of anxiety-related symptoms during the past two weeks. Each item is rated on a 4-point scale: 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in sleep problems measured by the Sleep Disturbance Scale for Children
Sleep problems will be assessed using the Sleep Disturbance Scale for Children (SDSC). The SDSC is a parent-rated questionnaire assessing sleep-related problems in children and adolescents. Items are rated according to the frequency or severity of sleep disturbances on a 5-point scale. The total score is calculated by summing item scores. Higher scores indicate more severe sleep disturbances.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in sensory processing symptoms measured by the Short Sensory Profile
Sensory processing symptoms will be assessed using the Short Sensory Profile (SSP). The SSP is a parent-rated questionnaire assessing sensory processing patterns and sensory-related behavioral responses in children. Each item is rated on a 5-point scale according to how frequently the child shows a specific sensory response. The total score is calculated by summing item scores. Lower scores generally indicate greater sensory processing difficulties, whereas higher scores indicate fewer sensory processing difficulties.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in selective attention performance during the joystick-based visual search task
Selective attention performance will be assessed using a joystick-based visual search task. Participants will be asked to identify the direction or location of a visual target and respond using a joystick. Behavioral outcome indices will include predefined task performance measures, such as reaction time, movement time, response accuracy, response variability, omission errors, commission errors, and other task-specific joystick response measures. In general, shorter reaction time and movement time, lower response variability, higher accuracy, and fewer errors indicate better selective attention performance.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in resting-state EEG spectral parameters
Resting-state electroencephalography will be recorded to assess spontaneous neural activity. EEG spectral outcomes will include power measures across predefined frequency bands and parameterized spectral measures derived from the power spectrum, such as aperiodic offset, aperiodic exponent, and periodic oscillatory components. These measures do not have a fixed clinical score range.
Measured: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start26 Mar 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies 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
- Crossover
- Model description
- This is a randomized, double-blind, sham-controlled crossover study. Participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences. One sequence will receive active 5-Hz fronto-parietal transcranial alternating current stimulation (tACS) first, followed by sham stimulation. The other sequence will receive sham stimulation first, followed by active tACS. Each participant will receive both interventions, with a washout period of at least 2 days between sessions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Jun Ou, Central South University
- Investigators
- Jianjun Ou, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633275
- Sponsor's protocol ID
- LYG20260017
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Neural Mechanisms of Fronto-Parietal Transcranial Alternating Current Stimulation in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07633275
- Acronym / sponsor ID
- LYG20260017
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 8 Jun 2026 (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.
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children and adolescents and is often associated with difficulties in attention, inhibitory control, working memory, and other executive functions. The fronto-parietal brain network is thought to play an important role in these cognitive functions. Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that may influence brain activity. This study aims to evaluate whether 5-Hz tACS targeting the right frontal and parietal regions can improve executive functioning in children and adolescents aged 6 to 18 years with ADHD. The study also aims to explore whether any effects of tACS are related to changes in brain activity measured by electroencephalography (EEG). Participants will receive both active tACS and sham stimulation in a randomized, double-blind, crossover design. Clinical symptoms, executive function performance, and EEG measures will be assessed before and after each stimulation session. The main hypothesis is that active fronto-parietal tACS will produce greater improvement in executive functioning than sham stimulation, and that these effects may be associated with changes in EEG-measured brain activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, sham-controlled crossover study. Participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences. One sequence will receive active 5-Hz fronto-parietal transcranial alternating current stimulation (tACS) first, followed by sham stimulation. The other sequence will receive sham stimulation first, followed by active tACS. Each participant will receive both interventions, with a washout period of at least 2 days between sessions.
| Arm | Type | Receives |
|---|---|---|
| Active tACS followed by sham stimulation | Experimental | Device: Active transcranial alternating current stimulation, Device: Sham transcranial alternating current stimulationParticipants randomized to this arm will receive active transcranial alternating current stimulation (tACS) first, followed by sham stimulation after a washout interval of at least 2 days. Both interventions will use the same right frontoparietal electrode montage. |
| Sham stimulation followed by active tACS | Experimental | Device: Active transcranial alternating current stimulation, Device: Sham transcranial alternating current stimulationParticipants randomized to this arm will receive sham stimulation first, followed by active transcranial alternating current stimulation (tACS) after a washout interval of at least 2 days. Both interventions will use the same right frontoparietal electrode montage. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 6-18 years, Han Chinese, and right-handed;
- Normal or corrected-to-normal vision and normal hearing;
- Meets the DSM-5 diagnostic criteria for attention-deficit/hyperactivity disorder, predominantly inattentive presentation;
- Meets the diagnostic threshold for inattention based on the parent-rated SNAP-IV scale;
- Performance on the symbol cancellation test, converted to a grade-standardized score, is below the average level;
Key exclusion criteria (6 listed)
- Meets diagnostic criteria for other major psychiatric disorders, such as schizophrenia or bipolar disorder;
- Has severe physical diseases, such as significant intracranial lesions, thyroid disease, epilepsy, congenital heart disease, severe hematological disease, systemic lupus erythematosus, or significant visual or hearing impairment;
- Has known obvious brain structural abnormalities based on available cranial imaging or medical history;
- Has severe neurological disease, a clear family history of hereditary neurological disorders, or other conditions associated with high neurological risk;
- Has metal implants or a cardiac pacemaker in the body, or has skull defects, holes, or fractures;
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 |
|---|---|---|
| Active transcranial alternating current stimulationActive transcranial alternating current stimulation (tACS) will be delivered over the right frontoparietal region using a multi-electrode montage. Electrodes will be placed at F4, F2, AF4, and F6 over the right frontal region, and at P4, CP4, P6, and PO4 over the right parietal region. F4 and P4 will be configured as return electrodes according to the stimulation protocol. The stimulation will be applied as a 5-Hz sinusoidal alternating current with a total current intensity of 2 mA. Each stimulation session will last 12 minutes, including 60-second ramp-up and 60-second ramp-down periods. | Device | Active tACS followed by sham stimulation, Sham stimulation followed by active tACS |
| Sham transcranial alternating current stimulationSham transcranial alternating current stimulation will use the same electrode montage, device appearance, and setup procedures as active tACS. Electrodes will be placed at F4, F2, AF4, and F6 over the right frontal region, and at P4, CP4, P6, and PO4 over the right parietal region. F4 and P4 will be configured as return electrodes as in the active stimulation condition. The sham procedure will include brief ramp-up and ramp-down periods of approximately 60 seconds to mimic the sensory experience of active stimulation, with no sustained current delivered. | Device | Active tACS followed by sham stimulation, Sham stimulation followed by active tACS |
Primary outcome
Change in attention performance measured by the Test of Attentional Performance for Children
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Attention performance will be assessed using the Test of Attentional Performance for Children, including seven child-adapted attention subtests covering alertness, distractibility, divided attention, cognitive flexibility, response inhibition, sustained attention, and visual scanning. Outcome indices include reaction time, reaction time variability, accuracy, omission errors, commission errors, and other task-specific performance measures. In general, shorter reaction time, lower reaction time variability, higher accuracy, and fewer errors indicate better attention performance.
Change in task-related EEG indices during the visual search task
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Task-related electroencephalography will be recorded during a visual search task in which participants identify the direction of a visual target and respond using a joystick. EEG outcomes will include event-related potential measures, such as N2pc amplitude and latency, time-frequency measures across predefined frequency bands, and alpha-band channel tuning function indices reflecting spatially selective neural responses. These measures do not have a fixed clinical score range.
8 secondary outcomes
Change in ADHD symptoms measured by the SNAP-IV Parent Rating Scale
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in abnormal behaviors measured by the Aberrant Behavior Checklist-Second Edition
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in depressive symptoms measured by the Patient Health Questionnaire-9
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-7 scale
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in sleep problems measured by the Sleep Disturbance Scale for Children
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in sensory processing symptoms measured by the Short Sensory Profile
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in selective attention performance during the joystick-based visual search task
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
Change in resting-state EEG spectral parameters
Time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.
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 Jul 2026.
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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.
Jianjun Ou principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial alternating current stimulation in people with Attention-Deficit/Hyperactivity Disorder, run by Central South University at 1 site in China.
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 7 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 1 Jul 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 China. 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. 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?
Change in attention performance measured by the Test of Attentional Performance for Children (time frame: Before the first stimulation session, immediately after the first stimulation session, before the second stimulation session after a washout interval of at least 2 days, and immediately after the second stimulation session.). The study lists 2 primary outcomes in all. 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 Jul 2026.