Non-Invasive Vagus Nerve Stimulation for Adolescents with Depression

Non-Invasive Vagus Nerve Stimulation for Adolescents with Depression - tVNS Youth Depression

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011112

Enrollment

Registered

2016-09-29

Start date

2016-12-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F32.1 F32.2

Interventions

Group 1: randomized within subject design

tVNS versus sham stimulation Arm 1: active stimulation of the vagus nerve using a commercial neurostimulation device VITOS (Cerbotec GmBH). Electrical stimulation is applied to the auricular branch o

Eligibility

Sex/Gender

All

Age

14 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1) therapy in our clinic 2) current depressive episode 3) informed consent of study participants and of a parent or a person having parental authority

Exclusion criteria

Exclusion criteria: 1) poor knowledge of the German language 2) intake of medicines containing glucocorticoids 3) pregnancy 4) primary neurological or endocrinological disease 5) acute psychotic symptoms 6) acute suicidality 7) any cardiovascular disease

Design outcomes

Primary

Measure	Time frame
The primary end point of the study is the assessment of performance on neuropsychological task on emotion recognition and emotion regulation (correct responses (i.e., action or classification) and response time (i.e., in milliseconds)). Adolescents repeat three neuropsychological task to assess emotion processing and emotion regulation under tVNS and sham. Emotion recognition is measured by the participants’ capability to correctly recognize (Test 1) and rate the intensity (Test 2) of key facial expressions using computerized task. The task comprises sets of stimuli that are presented cross-randomized (tVNS vs. sham). Reaction time in milliseconds and correct classifications are measured as outcome. Changes in emotion regulation are assessed using the emotional Go/No-Go paradigm (Test 3). The paradigm involves a continuously presented series of faces of certain emotional valences (e.g., happy, angry) composed of frequent “Go” cues (i.e. angry faces) to which patients respond as rapidly as possible (pressing key on keyboard) and infrequent “No-Go” (i.e., happy faces) cues to which patients do not respond and inhibit their response.	—

Measure

Time frame

The primary end point of the study is the assessment of performance on neuropsychological task on emotion recognition and emotion regulation (correct responses (i.e., action or classification) and response time (i.e., in milliseconds)). Adolescents repeat three neuropsychological task to assess emotion processing and emotion regulation under tVNS and sham. Emotion recognition is measured by the participants’ capability to correctly recognize (Test 1) and rate the intensity (Test 2) of key facial expressions using computerized task. The task comprises sets of stimuli that are presented cross-randomized (tVNS vs. sham). Reaction time in milliseconds and correct classifications are measured as outcome. Changes in emotion regulation are assessed using the emotional Go/No-Go paradigm (Test 3). The paradigm involves a continuously presented series of faces of certain emotional valences (e.g., happy, angry) composed of frequent “Go” cues (i.e. angry faces) to which patients respond as rapidly as possible (pressing key on keyboard) and infrequent “No-Go” (i.e., happy faces) cues to which patients do not respond and inhibit their response.

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Secondary

Measure	Time frame
A continous ECG is recorded to quantify changes in heart rate varaibility and functional near infrared spectroscopy (fNIRS) is used to quantify oxygenation of the prefrontal cortex as secondary endpoints of the trial.	—

Countries

Germany

Contacts

Public ContactJulian Koenig

Klinik für Kinder- und Jugendpsychiatrie

julian.koenig@med.uni-heidelberg.de06221 5638640

Outcome results

None listed

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