Attention DifficultiesNCT05834920
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
A study testing Transcranial pulse stimulation (TPS) and Neurofeedback in people with Attention Difficulties, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Difficulties
- What is being tested?
- Transcranial pulse stimulation (TPS) and Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Mar 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20 years and above
- Right-handed
- Normal/corrected hearing and vision
- Having basic literacy skills
- Having sustained attention scores below the threshold
Who cannot join
- Having medical history related to brain
- Having mild cognitive impairment
- Showing symptoms of depression and anxiety
- Having intellectual disability based on IQ scores
- Having diagnoses of any psychiatric or cognitive disorders besides attention deficit hyperactivity disorder (ADHD) inattentive and combined types
- Having long-term history of smoking cigarettes
Show all 10Show fewer
- Engaged in alcohol and/or substance abuse
- Having history of hemophilia or other blood clotting disorders or thrombosis
- Having corticosteroid treatment within the last six weeks before first intervention
- Having contraindications for MRI scanning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
HKU InnoCentre of Clinical Neuropsychology
Hong Kong
Maria T Wijaya, PhD, (852) 3917-8927, mtwijaya@hku.hk
About this study
The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.
- Conditions
- Attention Difficulties
- Being tested
- Transcranial pulse stimulation (TPS), Neurofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial pulse stimulation (TPS)Device
Participants will be treated with the TPS device NEUROLITH (Storz Medical AG). Treatments will be administered for up to 12 sessions within 4 weeks, each session consisting of 6000 TPS pulses of 0.2 mJ/mm².
NeurofeedbackDevice
Participants will engage in a neurofeedback game designed to increase the ratio of theta/beta frequency bands in electroencephalography measurement. This intervention will be delivered for up to 12 sessions within 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Active comparator | Not described Receives: Device: Neurofeedback |
| Transcranial pulse stimulation | Experimental | Not described Receives: Device: Transcranial pulse stimulation (TPS) |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Conners' Continuous Performance Test 3rd Edition
The Conners' Continuous Performance Test (CPT) measures inattentiveness, impulsivity, sustained attention, and vigilance. Participants are required to push the spacebar when any letter, except "X", appears. Performances are measured in raw scores and standardized T scores. T scores between 45-54 indicate average performance, higher or lower scores indicate atypical performance.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in gradCPT continuous performance test
The GradCPT is a continuous performance test to measure sustained attention. It has been shown to reliably indicate attentional fluctuation over time. Participants are required to respond to frequently presented city scene and inhibit responses to infrequently presented mountain scene. The sequence of visual stimuli is presented with gradual transitions to minimize involuntary attention capture by abrupt stimulus onset and offset. The main outcome of interest is reaction times variability, with higher variability indicating poorer sustained attention.
Measured: Baseline, week 4, week 8, week 12, week 16
Secondary outcomes (9)
Change from baseline in Stroop task
The Victoria version of the Stroop task is a validated means of measuring the ability to inhibit cognitive interference. Over three tasks of increasing difficulty level, participants are asked to identify colors as they appear on stimulus flash cards. These colors are randomly ordered either as dots, noncolor words, or noncorresponding color words. Performance is measured by reaction times and accuracy. Shorter reaction times and higher accuracy indicate better ability to inhibit cognitive interference.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in General Health Questionnaire
The General Health Questionnaire (GHQ) measures psychological well-being. It comprises 12 self-report questions, each assessing the severity of a mental problem over the past few weeks. Total scores range from 0 to 36 with a higher score indicating poorer psychological states.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Goal Orientation Scale
The Goal Orientation Scale measures how individuals interpret and respond to achievement situations. It comprises three subscales. The present study uses only the learning goal orientation subscale which consists of 5 self-report items measuring the desire to develop the self by acquiring new skills, mastering new situations, and improving one's competence. Total scores range from 5 to 35 with higher scores indicating greater learning goal orientation.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in N-back task
The N-back task measures working memory function. Participants are presented a sequence of numbers ranging from 0 to 9 one-by-one. For each, they are required to decide whether the current stimulus is the same as the one presented two trials ago. Performance is measured by reaction times and accuracy. Shorter reaction times and higher accuracy indicate better working memory.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Color Trails Test
The Color Trails Test (CTT) is used to assess attention shifting (i.e., the ability to alternate attention between two goals) and processing speed (i.e., the speed with which a cognitive operation is carried out). The test comprises two parts: CTT1 requires participants to connect a series of numbered circles that are randomly printed on a sheet of paper and CTT2 requires participants to connect numbered circles from 1 to 25 alternating between two colors (pink and yellow). Performance is measured by reaction times with faster reaction times indicating better flexibility and speed.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Attentional Control Scale
The Attentional Control Scale is a self-report measure of attentional control. It consists of two subscales which measure selective attention and attention shifting respectively. Total scores range from 20 to 80 with higher scores indicating better attentional control.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Rosenberg Self-esteem Scale
The Rosenberg Self-Esteem Scale is a 10-item self-report questionnaire which measures global self-esteem by measuring both positive and negative feeling about the self. Scores range from 10 to 40 with higher scores reflecting higher self-esteem.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Social Connectedness Scale
The Social Connectedness Scale comprises 8 self-report items measuring three aspects of belongingness: connectedness, affiliation, and companionship. Total scores range from 8 to 48 with higher scores indicating higher sense of social connectedness.
Measured: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire comprising two subscales which assess levels of anxiety and depression respectively. Total scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety or depression.
Measured: Baseline, week 4, week 8, week 12, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start17 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention DifficultiesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Teresa Wijaya, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834920
- Sponsor's protocol ID
- HKUNFBTPS
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
- ClinicalTrials.gov ID
- NCT05834920
- Acronym / sponsor ID
- HKUNFBTPS
- Conditions
- Attention Difficulties
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Apr 2023 (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.
The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Active comparator | Device: Neurofeedback |
| Transcranial pulse stimulation | Experimental | Device: Transcranial pulse stimulation (TPS) |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20 years and above
- Right-handed
- Normal/corrected hearing and vision
- Having basic literacy skills
- Having sustained attention scores below the threshold
Key exclusion criteria (10 listed)
- Having medical history related to brain
- Having mild cognitive impairment
- Showing symptoms of depression and anxiety
- Having intellectual disability based on IQ scores
- Having diagnoses of any psychiatric or cognitive disorders besides attention deficit hyperactivity disorder (ADHD) inattentive and combined types
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 stimulation (TPS)Participants will be treated with the TPS device NEUROLITH (Storz Medical AG). Treatments will be administered for up to 12 sessions within 4 weeks, each session consisting of 6000 TPS pulses of 0.2 mJ/mm². | Device | Transcranial pulse stimulation |
| NeurofeedbackParticipants will engage in a neurofeedback game designed to increase the ratio of theta/beta frequency bands in electroencephalography measurement. This intervention will be delivered for up to 12 sessions within 4 weeks. | Device | Neurofeedback |
Primary outcome
Change from baseline in Conners' Continuous Performance Test 3rd Edition
Time frame: Baseline, week 4, week 8, week 12, week 16
The Conners' Continuous Performance Test (CPT) measures inattentiveness, impulsivity, sustained attention, and vigilance. Participants are required to push the spacebar when any letter, except "X", appears. Performances are measured in raw scores and standardized T scores. T scores between 45-54 indicate average performance, higher or lower scores indicate atypical performance.
Change from baseline in gradCPT continuous performance test
Time frame: Baseline, week 4, week 8, week 12, week 16
The GradCPT is a continuous performance test to measure sustained attention. It has been shown to reliably indicate attentional fluctuation over time. Participants are required to respond to frequently presented city scene and inhibit responses to infrequently presented mountain scene. The sequence of visual stimuli is presented with gradual transitions to minimize involuntary attention capture by abrupt stimulus onset and offset. The main outcome of interest is reaction times variability, with higher variability indicating poorer sustained attention.
9 secondary outcomes
Change from baseline in Stroop task
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in General Health Questionnaire
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Goal Orientation Scale
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in N-back task
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Color Trails Test
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Attentional Control Scale
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Rosenberg Self-esteem Scale
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Social Connectedness Scale
Time frame: Baseline, week 4, week 8, week 12, week 16
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, week 4, week 8, week 12, week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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.
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 (TPS) and Neurofeedback in people with Attention Difficulties, run by The University of Hong Kong 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 10 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: looking for participants now, as of the sponsor's last update on 5 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria T Wijaya, PhD ((852) 3917-8927, mtwijaya@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Conners' Continuous Performance Test 3rd Edition (time frame: Baseline, week 4, week 8, week 12, week 16). 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 5 Mar 2025.