ADHDNCT05422274

Effect of Transcranial Pulse Stimulation on ADHD

A study testing Transcranial Pulse Stimulation in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: ADHD
What is being tested?: Transcranial Pulse Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteHong Kong
Study dates: 1 Jun 2022to 13 Jan 2023
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

have a confirmed diagnosis of ADHD according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association;
ethic Chinese, aged 12-17, with no co-morbidity of other mental disorders (e.g., Intellectual Disability Disorder) and organic brain diseases that affected cognitive functions;
no severe systemic diseases including heart, liver, lung, and kidney diseases;
have an IQ >80 by Stanford-Binet Intelligence Scales, 5th Edition (SB-5);
written consent by parents.

Who cannot join

SNAP IV score <1;
not taking ADHD medications in the past 2-4 weeks;
treated with TMS/rTMS/tDCS or electroconvulsive therapy in the past 12 months;
taking monoamine oxidase inhibitors in the past 14 days;
have a history of epilepsy, brain trauma, brain surgery/brain tumour, brain aneurysm or other concomitant unstable major medical conditions like haemophilia or other blood clotting disorders or thrombosis;
significant communicative impairments;

Show all 9Show fewer

having metal implants in the brain treatment region /artificial cardiac pacemaker in-situ;
taking corticosteroid treatment within the last six weeks before the first TPS treatment;
have a history of micro-cavernomas.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Nursing HongKongPolyU
Hong Kong

Other trials in Hong Kong

About this study

Official title: Evaluating the Efficacy and Safety of Transcranial Pulse Stimulation on Young Adolescents with Attention-Deficit-Hyperactivity Disorder- a Pilot Randomized, Double-blinded, Sham-controlled Trial

This is the first nationwide study using Transcranial Pulse Stimulation to evaluate its efficacy and safety on 30 young adolescents with ADHD. Six verum/ shamTPS sessions will be delivered to all subjects on a 1: 1 ratio, balanced by gender and age. Attention deficit, hyperactivity, impulsivity, and oppositional defiance will be the primary outcome. Secondary outcomes include ADHD severity, frequency of inattention, hyperactivity, impulsivity, executive function and neural connectivity changes via neuroimaging. Results emerging from this study will generate new knowledge to ascertain whether TPS can be used as a top-on treatment in ADHD.

Read the detailed description

Objectives of the study

To evaluate the efficacy and safety of TPS on young adolescents (12-17 years) with ADHD in Hong Kong.
To examine the association between TPS and ADHD core symptom severity, executive function, inattention, hyperactivity, impulsivity, and oppositional defiance.
To examine the brain functional connectivity changes immediately after the 2-week TPS treatment via neuroimaging.

Expected outcomes/Hypotheses:

Participants in the verum TPS group or the sham TPS group will have <5% somatic discomfort in the 2-week TPS intervention and that TPS is a safe intervention on young adolescents with ADHD.
Participants in the verum TPS group will have 30% reduction in the Swanson, Nolan, and Pelham Rating Scale (SNAP IV score) (i.e., attention deficit, hyperactivity impulse and oppositional defiance) after 2-weeks TPS treatment compared with the sham TPS group and be maintained at the 1- month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in the ADHD symptoms and behaviour compared with the sham TPS group after 2-weeks TPS treatment and be maintained at the 1-month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in executive function after 2 weeks TPS treatment compared with the sham TPS group and be maintained at the 1-month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in both attention deficit \& reduction in hyperactivity, impulsivity after 2 weeks TPS treatment compared with the sham TPS group, and be maintained at the 1 month \& 3-month follow-up.
Participants in the verum TPS group will have more brain connectivity changes after 2-weeks TPS compared with the sham TPS group and be maintained at the 1 month \& 3-month follow-up.

Design: This is a two-armed, randomized, double-blind, sham-controlled trial.

Sample size:

To the best of our knowledge, there is no interventional study evaluating the efficacy of TPS on ADHD. Based on our previous open label pilot RCT 37 evaluating TPS on adults with Major Depressive Disorder that showed a large effect size (f = 0.47), we hypothesize a large effect of TPS in this study. We used G*power version 3.1.9.4 to calculate the target sample size. With a statistical power of 95% and a statistical significance level at 0.05 to detect a large between-groups effect size (f) of 0.47 with 4 measurement time points, each group will require 15 subjects. A total sample of 30 is required in this trial. The attrition rate in our pilot MDD trial was 0%. We expect that the attrition rate in this ADHD trial would be <5%. Subject dropping out the 2-week intervention period will be replaced by another enrolled subject in this pilot study.

Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time. Participants will be followed up immediately after post-stimulation in Week 2, and at 1-month and 3- month period after the intervention. The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on improving inattention and hyperactivity.

Conditions: ADHD
Being tested: Transcranial Pulse Stimulation
Keywords: Efficacy and Safety, Transcranial Pulse 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.

Transcranial Pulse StimulationDevice
A total of 36 participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up immediately after the post-stimulation and at 1-month and 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on improving inattention and hyperactivity .

Study groups in NCT05422274
Study group	Role	What they receive
Transcranial Pulse Stimulation (TPS group)	Experimental	Subjects in the TPS group will be given 6 verum TPS sessions (Pulse: 800 / session) across two weeks time, with 3 sessions per week. Receives: Device: Transcranial Pulse Stimulation
Sham TPS Group	Sham comparator	Subjects in the Sham TPS group will be given 6 sham TPS sessions across two weeks time, with 3 sessions per week. Receives: Device: Transcranial Pulse Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Attention deficit, hyperactivity impulse and oppositional defiance
The Swanson, Nolan, and Pelham Rating Scale (SNAP IV) will be used to measure participants' attention deficit, hyperactivity impulse and oppositional defiance. SNAP IV consists of 26 items summarized into three factors: attention deficit, hyperactivity impulse, and oppositional defiance. Parents based on their general impressions on their children and rate the severity of symptoms on a Likert scale (0-3). Mean score <1 indicate "normal" or "remission"; Mean score of 1 is defined as the demarcation for attention deficit and hyperactivity impulsivity; mean score >2 indicated "abnormal".
SNAP-IV is a reliable and valid scale used in RCTs and has good psychometric properties in the Chinese population.
Measured: Changes in SNAP-IV scores from baseline at 3 months

Secondary outcomes (4)

Clinical global impression
CGI-S is a 7-point clinician rating scale is based upon observed and reported symptoms, behaviour, and function in the past seven days. CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Changes in CGI from baseline at 3 months
Executive function
Stroop test is a neuropsychological test commonly used to assess the inhibition control component of executive function and test the subject's ability to inhibit cognitive interference that occurs when the processing the target stimulus feature is impeded by the simultaneous processing of a second stimulus attribute.
Measured: Changes in Stroop test from baseline at 3 months
The ADHD Rating Scale-IV
ADHD RS-IV is a widely used ADHD scale comprising 18 items. Participant's parent rates the frequency of each symptom on the scale. Each item scores on a 4-point Likert scale of 0-3 (0: never or rarely; 1: sometimes; 2: often; 3: very often). The 9 odd items evaluate attention deficits, composing the Inattention subscale (or IA); the 9 even items evaluate Hyperactivity Impulsivity, composing the Hyperactivity Impulsivity (or HI) subscale; the total score is the sum of all the scores on the 18 items. The ADHD RS-IV is a reliable and valid scale in the Chinese population.
Measured: Changes in ADHD RS-IV from baseline at 3 months
Neuroimaging
Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain.
Measured: MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202213 Jan 2023

First posted16 Jun 2022
Study start1 Jun 2022
Primary completion13 Jan 2023
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ADHDStudies 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
Model description: This is a randomized, double-blinded, sham-controlled trial.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05422274
Sponsor's protocol ID: HongKongPU_HSEARS20220518006
Status last verified: Sep 2024
First submitted: 13 Jun 2022
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cheung T, Yee BK, Chau B, Lam JYT, Fong KH, Lo H, Li TMH, Li AM, Sun L, Beisteiner R, Cheng CPW. Efficacy and safety of transcranial pulse stimulation in young adolescents with attention-deficit/hyperactivity disorder: a pilot, randomized, double-blind, sham-controlled trial. Front Neurol. 2024 May 9;15:1364270. doi: 10.3389/fneur.2024.1364270. eCollection 2024.
PubMed 38784916
Cheung T, Chau B, Fong KH, Lam JYT, Lo H, Li MH, Li AMMC, Beisteiner R, Lei S, Yee BK, Cheng CPW. Evaluating the efficacy and safety of transcranial pulse stimulation on adolescents with attention deficit hyperactivity disorder: Study protocol of a pilot randomized, double-blind, sham-controlled trial. Front Neurol. 2023 Mar 28;14:1076086. doi: 10.3389/fneur.2023.1076086. eCollection 2023.
PubMed 37056363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy and Safety of Transcranial Pulse Stimulation on Young Adolescents with Attention-Deficit-Hyperactivity Disorder- a Pilot Randomized, Double-blinded, Sham-controlled Trial
ClinicalTrials.gov ID: NCT05422274
Acronym / sponsor ID: HongKongPU_HSEARS20220518006
Conditions: ADHD
Keywords: Efficacy and Safety, Transcranial Pulse Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 16 Jun 2022 (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.

Detailed description

Objectives of the study

To evaluate the efficacy and safety of TPS on young adolescents (12-17 years) with ADHD in Hong Kong.
To examine the association between TPS and ADHD core symptom severity, executive function, inattention, hyperactivity, impulsivity, and oppositional defiance.
To examine the brain functional connectivity changes immediately after the 2-week TPS treatment via neuroimaging.

Expected outcomes/Hypotheses:

Participants in the verum TPS group or the sham TPS group will have <5% somatic discomfort in the 2-week TPS intervention and that TPS is a safe intervention on young adolescents with ADHD.
Participants in the verum TPS group will have 30% reduction in the Swanson, Nolan, and Pelham Rating Scale (SNAP IV score) (i.e., attention deficit, hyperactivity impulse and oppositional defiance) after 2-weeks TPS treatment compared with the sham TPS group and be maintained at the 1- month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in the ADHD symptoms and behaviour compared with the sham TPS group after 2-weeks TPS treatment and be maintained at the 1-month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in executive function after 2 weeks TPS treatment compared with the sham TPS group and be maintained at the 1-month \& 3-month follow-up.
Participants in the verum TPS group will have 30% improvement in both attention deficit \& reduction in hyperactivity, impulsivity after 2 weeks TPS treatment compared with the sham TPS group, and be maintained at the 1 month \& 3-month follow-up.
Participants in the verum TPS group will have more brain connectivity changes after 2-weeks TPS compared with the sham TPS group and be maintained at the 1 month \& 3-month follow-up.

Design: This is a two-armed, randomized, double-blind, sham-controlled trial.

Sample size:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a randomized, double-blinded, sham-controlled trial.

Arm	Type	Receives
Transcranial Pulse Stimulation (TPS group)	Experimental	Device: Transcranial Pulse StimulationSubjects in the TPS group will be given 6 verum TPS sessions (Pulse: 800 / session) across two weeks time, with 3 sessions per week.
Sham TPS Group	Sham comparator	Device: Transcranial Pulse StimulationSubjects in the Sham TPS group will be given 6 sham TPS sessions across two weeks time, with 3 sessions per week.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

have a confirmed diagnosis of ADHD according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association;
ethic Chinese, aged 12-17, with no co-morbidity of other mental disorders (e.g., Intellectual Disability Disorder) and organic brain diseases that affected cognitive functions;
no severe systemic diseases including heart, liver, lung, and kidney diseases;
have an IQ >80 by Stanford-Binet Intelligence Scales, 5th Edition (SB-5);
written consent by parents.

Key exclusion criteria (9 listed)

SNAP IV score <1;
not taking ADHD medications in the past 2-4 weeks;
treated with TMS/rTMS/tDCS or electroconvulsive therapy in the past 12 months;
taking monoamine oxidase inhibitors in the past 14 days;
have a history of epilepsy, brain trauma, brain surgery/brain tumour, brain aneurysm or other concomitant unstable major medical conditions like haemophilia or other blood clotting disorders or thrombosis;

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 Pulse StimulationA total of 36 participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up immediately after the post-stimulation and at 1-month and 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on improving inattention and hyperactivity .	Device	Sham TPS Group, Transcranial Pulse Stimulation (TPS group)

Primary outcome

Attention deficit, hyperactivity impulse and oppositional defiance
Time frame: Changes in SNAP-IV scores from baseline at 3 months
The Swanson, Nolan, and Pelham Rating Scale (SNAP IV) will be used to measure participants' attention deficit, hyperactivity impulse and oppositional defiance. SNAP IV consists of 26 items summarized into three factors: attention deficit, hyperactivity impulse, and oppositional defiance. Parents based on their general impressions on their children and rate the severity of symptoms on a Likert scale (0-3). Mean score <1 indicate "normal" or "remission"; Mean score of 1 is defined as the demarcation for attention deficit and hyperactivity impulsivity; mean score >2 indicated "abnormal". SNAP-IV is a reliable and valid scale used in RCTs and has good psychometric properties in the Chinese population.

4 secondary outcomes

Clinical global impression
Time frame: Changes in CGI from baseline at 3 months
Executive function
Time frame: Changes in Stroop test from baseline at 3 months
The ADHD Rating Scale-IV
Time frame: Changes in ADHD RS-IV from baseline at 3 months
Neuroimaging
Time frame: MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation

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 13 Mar 2025.
Derived from this study: PubMed 38784916Cheung T, Yee BK, Chau B, Lam JYT, Fong KH, Lo H, Li TMH, Li AM, Sun L, Beisteiner R, Cheng CPW. Efficacy and safety of transcranial pulse stimulation in young adolescents with attention-deficit/hyperactivity disorder: a pilot, randomized, double-blind, sham-controlled trial. Front Neurol. 2024 May 9;15:1364270. doi: 10.3389/fneur.2024.1364270. eCollection 2024.
Derived from this study: PubMed 37056363Cheung T, Chau B, Fong KH, Lam JYT, Lo H, Li MH, Li AMMC, Beisteiner R, Lei S, Yee BK, Cheng CPW. Evaluating the efficacy and safety of transcranial pulse stimulation on adolescents with attention deficit hyperactivity disorder: Study protocol of a pilot randomized, double-blind, sham-controlled trial. Front Neurol. 2023 Mar 28;14:1076086. doi: 10.3389/fneur.2023.1076086. eCollection 2023.
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.

Teris Cheung, PhD principal investigator

HongKongPolyU

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 Pulse Stimulation in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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 5 inclusion and 9 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 13 Mar 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 Hong Kong. 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?

Attention deficit, hyperactivity impulse and oppositional defiance (time frame: Changes in SNAP-IV scores from baseline at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422274, which also lists 2 linked publications.

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 13 Mar 2025.