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Evaluation of Transauricular Vagus Nerve Stimulation in Children and Adolescents with Hyperarousal

Evaluation of Transauricular Vagus Nerve Stimulation in Children and Adolescents with Hyperarousal - EVAK

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039389
Enrollment
40
Registered
2026-03-03
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

F93

Interventions

Group 1: Intervention Arm (tVNS + guided imagery) Participants receive 10 sessions of transauricular vagus nerve stimulation (tVNS) combined with standardized guided imagery over 10 consecutive days.

Sponsors

Universitätsmedizin Rostock
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: Inpatient treatment in a child and adolescent psychiatric setting. Clinically relevant hyperarousal, defined as increased psychophysiological activation (e.g., pronounced inner tension, autonomic hyperreactivity, emotional dysregulation), based on clinical assessment during treatment. Sufficient language and cognitive abilities to participate in questionnaires and the intervention. Written informed consent from legal guardians and assent from the child/adolescent.

Exclusion criteria

Exclusion criteria: Neurological disorders associated with increased seizure risk or untreated epilepsy. Implanted electronic medical devices (e.g., pacemaker). Acute psychotic symptoms. Severe cognitive impairment preventing participation in the intervention or assessments. Dermatological conditions at the electrode placement site. Concurrent participation in another interventional study.

Design outcomes

Primary

MeasureTime frame
Change in heart rate variability (RMSSD derived from ECG) during the resting phase (10 minutes prior to the intervention) from Day 1 to Day 10 between groups (tVNS + guided imagery vs. guided imagery only).

Secondary

MeasureTime frame
Change in self-reported hyperarousal (PH-C total score) and connectivity in EEG from Day 1 to Day 10 between groups (tVNS + guided imagery vs. guided imagery only).

Countries

Germany

Contacts

Public ContactHannes Brehme

Universitätmedizin Rostock, Klinik für Psychiatrie, Neurologie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter, Department für Psychosoziale Medizin

hannes.brehme@med.uni-rostock.de+49 381 494 4611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026