Effect of Transcranial Pulse Stimulation on ADHD

NCT05422274 | Completed DMC

• 1 other identifier: HongKongPU_HSEARS20220518006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD

Keywords

Efficacy and Safety; Transcranial Pulse Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes in SNAP-IV scores from baseline at 3 months

Secondary Outcomes (4)

• Clinical global impression

  Changes in CGI from baseline at 3 months

• Executive function

  Changes in Stroop test from baseline at 3 months

• The ADHD Rating Scale-IV

  Changes in ADHD RS-IV from baseline at 3 months

• Neuroimaging

  MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation

Study Arms (2)

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.

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.

Device: Transcranial Pulse Stimulation

Interventions

Transcranial Pulse Stimulation DEVICE

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 .

Sham TPS Group; Transcranial Pulse Stimulation (TPS group)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing HongKongPolyU

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 38784916 DERIVED

• 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.

  PMID: 37056363 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Teris Cheung, PhD

  HongKongPolyU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind. Participants and interventionists will be blinded to the random allocation to either the verum TPS group or the sham TPS group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blinded, sham-controlled trial.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 1, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)