- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633275
Fronto-Parietal Transcranial Alternating Current Stimulation for ADHD in Children and Adolescents
June 3, 2026 updated by: Jian-Jun Ou, Central South University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianjun Ou
- Phone Number: +86 17775861486
- Email: oujianjun@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- Department of Psychiatry, The Second Xiangya Hospital of Central South University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active tACS followed by sham stimulation
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.
|
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 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.
|
|
Experimental: Sham stimulation followed by active tACS
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.
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
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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.
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianjun Ou, Central South University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2026
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
June 3, 2026
First Submitted That Met QC Criteria
June 3, 2026
First Posted (Actual)
June 8, 2026
Study Record Updates
Last Update Posted (Actual)
June 8, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYG20260017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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