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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real TPS group | Experimental |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial pulse stimulation | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg S. Kranz, PhD | The Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georg Kranz, PhD | Hong Kong | Hung Hom, Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41420421 | Derived | 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. |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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 |