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Brainwave Entrainment and Stimulation

Brainwave Entrainment and Stimulation - BEATS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56492
Enrollment
56
Registered
2023-07-11
Start date
2024-06-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

trauma- and stressor-related disorder

Interventions

TACS is applied to the bilateral dorsolateral prefrontal cortex (DLPFC) at a frequency of 5 Hz with an intensity of 2 mA (peak-to-peak) in the active tACS group. In the control group (sham stimulati

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age: 18 years or older - People with uniformed professions or post-active military veterans - Treatment with protocolized exposure-based therapy sessions for anxiety disorders or trauma- and stressor-related disorders (according to the Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, criteria), e.g. o Cognitive behavioural therapy with exposure, among which prolonged exposure (PE) o Narrative exposure therapy (NET) o Eye Movement Desensitization and Reprocessing (EMDR) therapy - Willingness and ability to understand the nature and content of the study, to participate and to comply with the study requirements - Willingness and ability to give written informed consent - Provide written informed consent

Exclusion criteria

Exclusion criteria: - Large metal or ferromagnetic objects in or around the head area, such as electronic hearing devices, cochlear implants, deep brain stimulators, or metal fragments near the skull (except for a dental wire). - Opened skull or trepanation - Pacemaker or neurostimulator - Medication pump - Epilepsy or family history of epilepsy - Severe neurological condition or (a history of) brain damage - Severe psychiatric condition comorbidity (e.g. schizophrenia, addiction) - Skin damage or diseases around the intended tACS electrode sites (e.g. psoriasis, eczema) - Concurrent or recent (within previous month) neuromodulation / neurostimulation (e.g., tDCS, TMS) treatment or study - Pregnancy or possible pregnancy

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the stress response based on heart rate variability (HRV) and subjective units of distress (SUDs) during the exposure-based therapy sessions and subjective anxiety symptoms after the exposure-based therapy sessions.

Secondary

MeasureTime frame
Secondary study parameters are PTSD symptom severity and the influence of various baseline measures: resting-state heart rate variability, theta electroencephalography (EEG) activity, emotional working memory, stress hormone response, sleep quality and various mental health variables.

Countries

Netherlands

Contacts

Public ContactK Hendriks

Universitair Medisch Centrum Utrecht

k.hendriks-8@umcutrecht.nl0302502505

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026