Transcranial Pulse Stimulation on Motor Cortex

NCT06312930 | Completed DMC

• 1 other identifier: HSEARS20220816001-03
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance

  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

Study Arms (2)

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.

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.

Device: Transcranial pulse stimulation

Interventions

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)

Real TPS group; Sham TPS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Georg Kranz, PhD

Hong Kong, Hung Hom, Kowloon, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 41420421 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Georg S. Kranz, PhD

  The Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 15, 2024
• Study Start: March 14, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: July 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)