Transcranial Pulse Stimulation on Motor Cortex

NCT ID: NCT06312930

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2024-12-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real TPS group

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.

Group Type: EXPERIMENTAL

Transcranial pulse stimulation

Intervention Type: 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)

Sham TPS group

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.

Group Type: SHAM_COMPARATOR

Transcranial pulse stimulation

Intervention Type: 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)

Interventions

Transcranial pulse stimulation

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Georg Kranz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg S. Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Polytechnic University

Locations

Georg Kranz, PhD

Hong Kong, Hung Hom, Kowloon, Hong Kong

Countries

Hong Kong

Other Identifiers

HSEARS20220816001-03

Identifier Type: -

Identifier Source: org_study_id