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Recruiting NCT06635161

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

No phase Interventional Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trancranial pulse stimulation (without a stand-off device), Transcranial pulse stimulation (with Neurology stand-off device), Transcranial pulse stimulation (with a sham stand-off device).
Who it may be relevant to
Registry conditions: Healthy Adults. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The Chinese version of reading the mind in the eyes test [Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)]
  • The Balloon Analog Risk Task [Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)]
  • The Go/No-go task [Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)]
  • The counting Stroop task [Time frame: Baseline, midpoint (2 weeks after the first TPS session), endpoint (4 weeks after the first TPS session)]
Secondary outcome measures (1)
  • Magnetic resonance imaging measurement [Time frame: baseline (one week before the 1st TPS session), endpoint (4 weeks after the first TPS session)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT06635161 · HSEARS20240319006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗