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Transcranial Pulse Stimulation on Motor Cortex

Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, Sham-controlled, Pilot Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06312930
Enrollment
34
Registered
2024-03-15
Start date
2024-03-14
Completion date
2024-12-03
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Brief 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. 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.

Interventions

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)

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18 to 65 * No physical, neurological or psychiatric disorder * Right-handedness

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in movement time in nine-hole peg test after TPSImmediately 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 TPSPrimary 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 TPSImmediately 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 TPSPrimary 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.

Secondary

MeasureTime frameDescription
The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance30 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 TPSThe 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026