Healthy AdultsNCT06312930
Transcranial Pulse Stimulation on Motor Cortex
A study testing Transcranial pulse stimulation 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?
- Transcranial pulse stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Mar 2024to 3 Dec 2024
- 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
- No physical, neurological or psychiatric disorder
- Right-handedness
Who cannot join
- Background with neuroscience
- TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, 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. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.
- Conditions
- Healthy Adults
- Being tested
- Transcranial pulse stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial pulse stimulationDevice
A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2-0.25 mJ mm-2, ~5 Hz pulse frequency)
| Study group | Role | What they receive |
|---|---|---|
| Real TPS group | Experimental | 1. Healthy adults aged 18-65 years old will receive one single session of real TPS on the primary motor cortex.
2. Before and after TPS, participants will perform two visuomotor tasks (a simple reaction time task and a nine-hole peg test).
3. The stimulation target on the primary motor cortex will be determined by transcranial magnetic stimulation (TMS). Measurements of the resting motor threshold by TMS will be conducted for each participant before the real TPS session. Receives: Device: Transcranial pulse stimulation |
| Sham TPS group | Sham comparator | Sham stimulation comprises TPS on the vertex as the control region (sham control).
Stimulation duration, intensity, as well as pre- and post stimulation assessments are the same as in the experimental arm.
In this cross-over study, the order of the real and sham stimulation conditions will be randomized and separated by 24 hours. Receives: Device: Transcranial pulse stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement time in nine-hole peg test after TPS
Primary clinical outcome measure will be a change in movement time in nine-hole peg test after TPS. Less movement time is indicative of greater improvement in hand dexterity and motor function.
Measured: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Change in reaction time in Deary-Liewald reaction time task after TPS
Primary clinical outcome measure will be a change in reaction time in Deary-Liewald reaction time task after TPS. Less reaction time is indicative of greater improvement in motor function.
Measured: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Secondary outcomes (1)
The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance
The RMT will be measured before the TPS, which is indicative of the motor excitability. The investigators will explore the correlation between the RMT and post-TPS motor performance measured by the nine-hole peg test; as well as explore correlation between RMT and post-TPS motor performance measured by the Deary-Liewald reaction time task.
Measured: 30 minutes before TPS session, immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Mar 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 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 Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312930
- Sponsor's protocol ID
- HSEARS20220816001-03
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin PP, Chak IK, Kan RL, Jin MX, Zhang BB, Xia AW, Lin TT, Wang SX, Liu JH, Cheung T, Kranz GS. Effects of Transcranial Pulse Stimulation of the Primary Motor Cortex on Motor Performance in Healthy Adults: A Randomized Crossover Pilot Study. CNS Neurosci Ther. 2025 Dec;31(12):e70711. doi: 10.1002/cns.70711.
PubMed 41420421
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, Sham-controlled, Pilot Trial
- ClinicalTrials.gov ID
- NCT06312930
- Acronym / sponsor ID
- HSEARS20220816001-03
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 15 Mar 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. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real TPS group | Experimental | Device: Transcranial pulse stimulation1. Healthy adults aged 18-65 years old will receive one single session of real TPS on the primary motor cortex. 2. Before and after TPS, participants will perform two visuomotor tasks (a simple reaction time task and a nine-hole peg test). 3. The stimulation target on the primary motor cortex will be determined by transcranial magnetic stimulation (TMS). Measurements of the resting motor threshold by TMS will be conducted for each participant before the real TPS session. |
| Sham TPS group | Sham comparator | Device: Transcranial pulse stimulationSham stimulation comprises TPS on the vertex as the control region (sham control). Stimulation duration, intensity, as well as pre- and post stimulation assessments are the same as in the experimental arm. In this cross-over study, the order of the real and sham stimulation conditions will be randomized and separated by 24 hours. |
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
- No physical, neurological or psychiatric disorder
- Right-handedness
Key exclusion criteria (2 listed)
- Background with neuroscience
- TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.
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 single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2-0.25 mJ mm-2, ~5 Hz pulse frequency) | Device | Real TPS group, Sham TPS group |
Primary outcome
Change in movement time in nine-hole peg test after TPS
Time frame: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Primary clinical outcome measure will be a change in movement time in nine-hole peg test after TPS. Less movement time is indicative of greater improvement in hand dexterity and motor function.
Change in reaction time in Deary-Liewald reaction time task after TPS
Time frame: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Primary clinical outcome measure will be a change in reaction time in Deary-Liewald reaction time task after TPS. Less reaction time is indicative of greater improvement in motor function.
1 secondary outcome
The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance
Time frame: 30 minutes before TPS session, immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
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 1 Jul 2025.
- Derived from this study: PubMed 41420421Qin PP, Chak IK, Kan RL, Jin MX, Zhang BB, Xia AW, Lin TT, Wang SX, Liu JH, Cheung T, Kranz GS. Effects of Transcranial Pulse Stimulation of the Primary Motor Cortex on Motor Performance in Healthy Adults: A Randomized Crossover Pilot Study. CNS Neurosci Ther. 2025 Dec;31(12):e70711. doi: 10.1002/cns.70711.
- Individual participant dataSharing planned: No
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Healthy Participants
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 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 Transcranial pulse stimulation 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 2 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 1 Jul 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?
Change in movement time in nine-hole peg test after TPS (time frame: Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS). 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?
On the ClinicalTrials.gov record for NCT06312930, which also lists 1 linked publication.
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 1 Jul 2025.