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Transcranial ultrasonic stimulation of the human amygdala during fear learning

Transcranial ultrasonic stimulation of the human amygdala during fear learning - Amygdala stimulation during fear learning

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54249
Enrollment
67
Registered
2021-06-15
Start date
2022-04-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain

Interventions

Verum TUS targeted at the amygdala.

Sponsors

Radboud Universiteit Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Healthy participants between 18-40 years of age; - The ability and agreement to provide informed consent, and the ability to fulfil the study's requirements.

Exclusion criteria

Exclusion criteria: • Under 18 years of age • Current or planned pregnancy • Claustrophobia • A history or brain surgery or serious head trauma • A history of or any close relatives (parents, siblings, children) with epilepsy, convulsion, or seizure • Predisposition for fainting spells (syncope) • A cardiac pacemaker or intra-cardiac lines • An implanted neurostimulator • Implanted medication infusion device • Implanted metal devices or large ferromagnetic fragments in the head or upper body (excluding dental wire), or jewellery/piercing that cannot be removed • Use of a medical plaster that cannot or may not be taken off (e.g., nicotine plaster) • Cochlear implants • Metal in the brain, skull, or elsewhere in your body (fragments, clips, etc.) • Diagnosed neurological or psychiatric disorders • Use of psychoactive (prescription) medication (excluding anti-conception) • Skin disease at intended stimulation sites • The consumption of more than four alcoholic units within 24 hours before participation or any recreational drugs within 48 hours before participation

Design outcomes

Primary

MeasureTime frame
Electrodermal activity (EDA) is used to index differential skin-conductance responses (SCRs) to the conditioned stimuli (CS+ vs. CS-). EDA is measured using Ag/AgCl electrodes placed on the palmar side of the distal phalanges of the ring and little finger of the left hand. The main study parameter falls under the blanket approval for standard research (CMO2014/288, version 3; titled: *Imaging Human Cognition*).

Secondary

MeasureTime frame
- Heart rate (HR) is used to index differential heart rate responses (HRRs) to the conditioned stimuli (CS+ vs. CS-). HR is measured using electrocardiography (ECG), using lead electrodes attached to the skin surface. - Pupil diameter (PD) is used to index differential pupil dilation responses (PDRs) to the conditioned stimuli (CS+ vs. CS-). PD is recorded by video-based eye-tracking. The secondary study parameters fall under the blanket approval for standard research (CMO2014/288, version 3; titled: *Imaging Human Cognition*).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)