Healthy AdultsNCT06635161
Trancranial Pulse Stimulation on Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex
A study testing Trancranial pulse stimulation (without a stand-off device) and Transcranial pulse stimulation (with Neurology stand-off device) in people with Healthy Adults, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\'s disease and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Trancranial pulse stimulation (without a stand-off device) and Transcranial pulse stimulation (with Neurology stand-off device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Aug 2024to 31 Dec 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- Biological and mental health, based on a clinical interview
- Able to understand and follow instructions by the study team
Who cannot join
- Major internal diseases, neurological disorders, or mental disorders
- Having a metal implant in the brain
- Corticosteroid treatment within 6 weeks prior to inclusion
- Pregnancy or breastfeeding
- Common NIBS and MRI exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation, and intracranial metallic particles
- Previous TPS experience
- Color blindness
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong, Hung Hom, Kowloon
About this study
Official title: Neuromodulation With Transcranial Pulse Stimulation of the Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex in Healthy Adults: A Randomized, Single-blind, Three-arm, Sham-controlled, Pilot Trial
Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\'s disease and depression. Although TPS has the capability to noninvasively target deeper brain regions such as the dorsal anterior cingulate cortex (dACC) and anterior insula cortex (AIC), no TPS study has been conducted to investigate the feasibility and effectiveness of dACC or AIC stimulation. Here, a randomized, single-blind, sham-controlled clinical pilot trial is proposed to probe the effects of TPS over bilateral dACC and AIC on modulating cognitive, behavioral and emotional functions and functional connectivity of brain circuits.
- Conditions
- Healthy Adults
- Being tested
- Trancranial pulse stimulation (without a stand-off device), Transcranial pulse stimulation (with Neurology stand-off device), Transcranial pulse stimulation (with a sham stand-off device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trancranial pulse stimulation (without a stand-off device)Device
A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). No stand-off device will be used to target dorsal anteior cingulate cortex.
Transcranial pulse stimulation (with Neurology stand-off device)Device
A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A Neurology stand-off device will be used to target the anterior insula cortex.
Transcranial pulse stimulation (with a sham stand-off device)Device
A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A sham stand-off device will be used to target vertex.
| Study group | Role | What they receive |
|---|---|---|
| TPS on AIC | Experimental | 1. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral anterior insula cortex (AIC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral AIC will be determined by transforming MNI coordinates (left AIC: x=-41, y=6, z=3; right AIC: x=44, y=9, z=2) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, a standard stand-off device (Neurology) will be used when stimulating AIC. Receives: Device: Transcranial pulse stimulation (with Neurology stand-off device) |
| TPS on dACC | Experimental | 1. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral dorsal anterior cingulate cortex (dACC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral dACC will be determined by transforming MNI coordinates (left dACC: x=-4, y=26, z=45; right dACC: x=7, y=30, z=40) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, no stand-off device will be used when stimulating dACC. Receives: Device: Trancranial pulse stimulation (without a stand-off device) |
| sham TPS on vertex | Sham comparator | 1. Healthy adults aged 18-65 years old will receive ten sessions of sham TPS (1000 pulses per session) on the vertex within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the vertex will be determined by transforming MNI coordinates (x=0, y=-30, z=60) into the individual T1-weighted space. 4. A sham stand-off device will be used when stimulating the vertex. Receives: Device: Transcranial pulse stimulation (with a sham stand-off device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Chinese version of reading the mind in the eyes test
The Chinese version of reading the mind in the eyes test (RMET) will be used to assess the AIC function of empathy. In this test, participants will be presented with a series of 28 photographs of the eye region of the face, followed by four mental state terms. Participants will be asked to choose which of four words best describes what the person in the photograph is thinking, feeling, and expressing. The order of trial presentation within each run will be randomized. Participants will be told to complete the task as quickly as possible although they are not timed.
Measured: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The Balloon Analog Risk Task
The Balloon Analog Risk Task will be used to assess the AIC function of risky decision-making. Participants have to inflate a virtual balloon that can either grow larger or explode. Each time participants pump up the balloon, they accumulate money, but each pump also carries the risk of the balloon exploding, which results in the participant losing all of their money from that balloon. In the task, participants will be required to complete 30 trials (balloons) with a maximum of 12 pumps. The probability of explosion will be increased with each pump from 2% for the first pump to 90% for the last pump.
Measured: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The Go/No-go task
The Go/No-go task (GNGT) will be used to assess the AIC and ACC function of response inhibition. The red circles and blue circles will serve as Go and No-go signals, respectively. Each trial will begin with the central fixation cross for a duration of 1000 ms, followed by a Go or No-go stimulus for 400 ms. A total of 100 trials will be randomly presented in two blocks, including high (50%) and low (20%) No-go trials. The participants will be instructed to respond as quickly as possible to the Go signal by pressing the space key on the keyboard with the right index finger and to withhold the response when a No-go signal appears. Before the test task, there will be a practice session with 20 trials. At the end of each trial in the test task, participants will receive feedback for 1000 ms indicating their answer is correct or not.
Measured: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The counting Stroop task
The counting Stroop task conflict will be used to assess the dACC function of the error monitoring. Participants will be required to report, via key-press, the number of identical words they see on a monitor, regardless of the word\'s meaning, as quickly and accurately as possible. The alphabets (A, S, K, L) on the keyboard correspond to the number of words (A to 1, S to 2, K to 3, L to 4). In incongruent blocks, the stimuli consisted of Chinese number words such as "一", "二", "三" and "四", while the number of words and meaning will be always inconsistent. During the neutral blocks, Chinese words such as "了", "人", "手", "口" which are irrelevant to the number will be displayed. Both sets of stimuli are common Chinese words with matched visual complexity. Each stimulus will change every 1.5 seconds. The inter-trial interval will be 500 ms. The task consisted of four 48-second blocks of 24 neutral trials alternating with four 48-second blocks of 24 incongruent trials.
Measured: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
Secondary outcomes (1)
Magnetic resonance imaging measurement
Participants will receive a 5-minute structural MRI scan using a Siemens 3T MAGNETOM Prisma system and a 64-channel head coil. The standard scanning parameters will be: TR/TE=2300/2.98 ms, flip angle = 9°, FOV=240x256x208 mm, voxel size=1x1x1 mm. A rs-fMRI scan of 8 minutes will be performed, during which subjects will be instructed to relax with eyes open and gaze at a cross displayed on the screen in front of them, allowing their mind to wander without focusing on anything specific. Rs-fMRI will be performed using a single-shot gradient-recalled EPI with TR/TE=607/32 ms, a FOV of 220x220x160 mm, and a voxel size of 2.5x2.5x2.5 mm with 64 slices (slice thickness = 2.5mm, interleaved series).
Measured: baseline (one week before the 1st TPS session), endpoint (4 weeks after the first TPS session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start5 Aug 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
- Investigators
- Georg S Kranz, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635161
- Sponsor's protocol ID
- HSEARS20240319006
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With Transcranial Pulse Stimulation of the Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex in Healthy Adults: A Randomized, Single-blind, Three-arm, Sham-controlled, Pilot Trial
- ClinicalTrials.gov ID
- NCT06635161
- Acronym / sponsor ID
- HSEARS20240319006
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Oct 2024 (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.
Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \& Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\'s disease and depression. Although TPS has the capability to noninvasively target deeper brain regions such as the dorsal anterior cingulate cortex (dACC) and anterior insula cortex (AIC), no TPS study has been conducted to investigate the feasibility and effectiveness of dACC or AIC stimulation. Here, a randomized, single-blind, sham-controlled clinical pilot trial is proposed to probe the effects of TPS over bilateral dACC and AIC on modulating cognitive, behavioral and emotional functions and functional connectivity of brain circuits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPS on AIC | Experimental | Device: Transcranial pulse stimulation (with Neurology stand-off device)1. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral anterior insula cortex (AIC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral AIC will be determined by transforming MNI coordinates (left AIC: x=-41, y=6, z=3; right AIC: x=44, y=9, z=2) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, a standard stand-off device (Neurology) will be used when stimulating AIC. |
| TPS on dACC | Experimental | Device: Trancranial pulse stimulation (without a stand-off device)1. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral dorsal anterior cingulate cortex (dACC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral dACC will be determined by transforming MNI coordinates (left dACC: x=-4, y=26, z=45; right dACC: x=7, y=30, z=40) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, no stand-off device will be used when stimulating dACC. |
| sham TPS on vertex | Sham comparator | Device: Transcranial pulse stimulation (with a sham stand-off device)1. Healthy adults aged 18-65 years old will receive ten sessions of sham TPS (1000 pulses per session) on the vertex within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the vertex will be determined by transforming MNI coordinates (x=0, y=-30, z=60) into the individual T1-weighted space. 4. A sham stand-off device will be used when stimulating the vertex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65
- Biological and mental health, based on a clinical interview
- Able to understand and follow instructions by the study team
Key exclusion criteria (7 listed)
- Major internal diseases, neurological disorders, or mental disorders
- Having a metal implant in the brain
- Corticosteroid treatment within 6 weeks prior to inclusion
- Pregnancy or breastfeeding
- Common NIBS and MRI exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation, and intracranial metallic particles
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 |
|---|---|---|
| Trancranial pulse stimulation (without a stand-off device)A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). No stand-off device will be used to target dorsal anteior cingulate cortex. | Device | TPS on dACC |
| Transcranial pulse stimulation (with Neurology stand-off device)A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A Neurology stand-off device will be used to target the anterior insula cortex. | Device | TPS on AIC |
| Transcranial pulse stimulation (with a sham stand-off device)A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A sham stand-off device will be used to target vertex. | Device | sham TPS on vertex |
Primary outcome
The Chinese version of reading the mind in the eyes test
Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The Chinese version of reading the mind in the eyes test (RMET) will be used to assess the AIC function of empathy. In this test, participants will be presented with a series of 28 photographs of the eye region of the face, followed by four mental state terms. Participants will be asked to choose which of four words best describes what the person in the photograph is thinking, feeling, and expressing. The order of trial presentation within each run will be randomized. Participants will be told to complete the task as quickly as possible although they are not timed.
The Balloon Analog Risk Task
Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The Balloon Analog Risk Task will be used to assess the AIC function of risky decision-making. Participants have to inflate a virtual balloon that can either grow larger or explode. Each time participants pump up the balloon, they accumulate money, but each pump also carries the risk of the balloon exploding, which results in the participant losing all of their money from that balloon. In the task, participants will be required to complete 30 trials (balloons) with a maximum of 12 pumps. The probability of explosion will be increased with each pump from 2% for the first pump to 90% for the last pump.
The Go/No-go task
Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The Go/No-go task (GNGT) will be used to assess the AIC and ACC function of response inhibition. The red circles and blue circles will serve as Go and No-go signals, respectively. Each trial will begin with the central fixation cross for a duration of 1000 ms, followed by a Go or No-go stimulus for 400 ms. A total of 100 trials will be randomly presented in two blocks, including high (50%) and low (20%) No-go trials. The participants will be instructed to respond as quickly as possible to the Go signal by pressing the space key on the keyboard with the right index finger and to withhold the response when a No-go signal appears. Before the test task, there will be a practice session with 20 trials. At the end of each trial in the test task, participants will receive feedback for 1000 ms indicating their answer is correct or not.
The counting Stroop task
Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
The counting Stroop task conflict will be used to assess the dACC function of the error monitoring. Participants will be required to report, via key-press, the number of identical words they see on a monitor, regardless of the word\'s meaning, as quickly and accurately as possible. The alphabets (A, S, K, L) on the keyboard correspond to the number of words (A to 1, S to 2, K to 3, L to 4). In incongruent blocks, the stimuli consisted of Chinese number words such as "一", "二", "三" and "四", while the number of words and meaning will be always inconsistent. During the neutral blocks, Chinese words such as "了", "人", "手", "口" which are irrelevant to the number will be displayed. Both sets of stimuli are common Chinese words with matched visual complexity. Each stimulus will change every 1.5 seconds. The inter-trial interval will be 500 ms. The task consisted of four 48-second blocks of 24 neutral trials alternating with four 48-second blocks of 24 incongruent trials.
1 secondary outcome
Magnetic resonance imaging measurement
Time frame: baseline (one week before the 1st TPS session), endpoint (4 weeks after the first TPS session)
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 9 Sep 2026.
- 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.
Georg S Kranz, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trancranial pulse stimulation (without a stand-off device) and Transcranial pulse stimulation (with Neurology stand-off device) in people with Healthy Adults, 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 3 inclusion and 7 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 9 Sep 2026. 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?
The Chinese version of reading the mind in the eyes test (time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)). The study lists 4 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 9 Sep 2026.