RecruitingNot ApplicableNCT06635161

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


Sponsor

The Hong Kong Polytechnic University

Enrollment

66 participants

Start Date

Aug 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • Age 18 to 65
  • Biological and mental health, based on a clinical interview
  • Able to understand and follow instructions by the study team

Exclusion Criteria6

  • Major internal diseases, neurological disorders, or mental disorders
  • Having a metal implant in the brain
  • Corticosteroid treatment within 6 weeks prior to inclusion
  • Pregnancy or breastfeeding
  • Previous TPS experience
  • Color blindness

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Interventions

DEVICETrancranial 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.

DEVICETranscranial 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.

DEVICETranscranial 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.


Locations(1)

The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Kowloon, Hong Kong

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NCT06635161


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