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

NCT ID: NCT06635161

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TPS on AIC

1\. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral anterior insula cortex (AIC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral AIC will be determined by transforming MNI coordinates (left AIC: x=-41, y=6, z=3; right AIC: x=44, y=9, z=2) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, a standard stand-off device (Neurology) will be used when stimulating AIC.

Group Type EXPERIMENTAL

Transcranial pulse stimulation (with Neurology stand-off device)

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 mJ mm-2, 4 Hz pulse frequency). A Neurology stand-off device will be used to target the anterior insula cortex.

TPS on dACC

1\. Healthy adults aged 18-65 years old will receive ten sessions of real TPS (1000 pulses per session) on the bilateral dorsal anterior cingulate cortex (dACC) within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the bilateral dACC will be determined by transforming MNI coordinates (left dACC: x=-4, y=26, z=45; right dACC: x=7, y=30, z=40) into the individual T1-weighted space. 4. To optimize the penetration depth of TPS pulses, no stand-off device will be used when stimulating dACC.

Group Type EXPERIMENTAL

Trancranial pulse stimulation (without a stand-off device)

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 mJ mm-2, 4 Hz pulse frequency). No stand-off device will be used to target dorsal anteior cingulate cortex.

sham TPS on vertex

1\. Healthy adults aged 18-65 years old will receive ten sessions of sham TPS (1000 pulses per session) on the vertex within 2 weeks (5 sessions per week). 2. Before and after TPS, participants will perform four psychological tasks (the reading the mind in the eyes test, the balloon analog risk task, the Go/No-go task, the counting stroop task). 3. The stimulation target on the vertex will be determined by transforming MNI coordinates (x=0, y=-30, z=60) into the individual T1-weighted space. 4. A sham stand-off device will be used when stimulating the vertex.

Group Type SHAM_COMPARATOR

Transcranial pulse stimulation (with a sham stand-off device)

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 mJ mm-2, 4 Hz pulse frequency). A sham stand-off device will be used to target vertex.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Georg Kranz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg S Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Georg Kranz, PhD

Role: CONTACT

+85227664838

Facility Contacts

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Georg Kranz, PhD

Role: primary

+852-27664838

Other Identifiers

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HSEARS20240319006

Identifier Type: -

Identifier Source: org_study_id

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