Clinical trial NCT06635161: Trancranial Pulse Stimulation on Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \&amp; Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\&#39;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 criteria: 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
* Common NIBS and MRI exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation, and intracranial metallic particles
* Previous TPS experience
* Color blindness

Primary outcomes:
measure: The Chinese version of reading the mind in the eyes test
timeFrame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
measure: The Balloon Analog Risk Task
timeFrame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
measure: The Go/No-go task
timeFrame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
measure: The counting Stroop task
timeFrame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)
Secondary outcomes:
measure: Magnetic resonance imaging measurement
timeFrame: baseline (one week before the 1st TPS session), endpoint (4 weeks after the first TPS session)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Hung Hom, Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Georg S Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References: