Fronto-Parietal Transcranial Alternating Current Stimulation for ADHD in Children and Adolescents

NCT07633275 | Recruiting

• 1 other identifier: LYG20260017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Device: Active transcranial alternating current stimulation; Device: Sham transcranial alternating current stimulation

Interventions

Active transcranial alternating current stimulation DEVICE

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.

Active tACS followed by sham stimulation; Sham stimulation followed by active tACS

Sham transcranial alternating current stimulation DEVICE

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.

Active tACS followed by sham stimulation; Sham stimulation followed by active tACS

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Department of Psychiatry, The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jianjun Ou

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Ou

CONTACT

+86 17775861486; oujianjun@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)