NCT06635161

Trancranial Pulse Stimulation on Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex

Neuromodulation With Transcranial Pulse Stimulation of the Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex in Healthy Adults: A Randomized, Single-blind, Three-arm, Sham-controlled, Pilot Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. Although TPS has the capability to noninvasively target deeper brain regions such as the dorsal anterior cingulate cortex (dACC) and anterior insula cortex (AIC), no TPS study has been conducted to investigate the feasibility and effectiveness of dACC or AIC stimulation. Here, a randomized, single-blind, sham-controlled clinical pilot trial is proposed to probe the effects of TPS over bilateral dACC and AIC on modulating cognitive, behavioral and emotional functions and functional connectivity of brain circuits.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DEVICE	Trancranial pulse stimulation (without a stand-off device)	A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). No stand-off device will be used to target dorsal anteior cingulate cortex.
DEVICE	Transcranial pulse stimulation (with Neurology stand-off device)	A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A Neurology stand-off device will be used to target the anterior insula cortex.
DEVICE	Transcranial pulse stimulation (with a sham stand-off device)	A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 μs) ultrasound pulses, 0.2 mJ mm-2, 4 Hz pulse frequency). A sham stand-off device will be used to target vertex.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-10-10
• Last updated: 2025-07-01

Locations

1 site across 1 country: Hong Kong