tVNS, Motivation, and Insulin Sensitivity

NANot yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 13, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Major Depressive Disorder (MDD)
Interventions
DEVICE

Transcutaneous non-invasive vagus nerve stimulation (tVNS)

To stimulate vagal afferents, the electrode will be placed at the cymba conchae of the right ear using a previously established conventional stimulation protocol (30 s ON, 30s OFF, 25 Hz frequency, 250 µs pulse widths; tVNS R device, tVNS Technologies GmbH, Erlangen, Germany). Stimulation intensity will be pre-set for each participant for the following stimulation period to correspond to a mild pricking sensation determined with a staircase procedure in the lab session.

DEVICE

Sham stimulation

The control intervention consists of a sham stimulation. The electrode will be placed at the earlobe, which is not innervated by vagal afferent fibers. To improve blinding, the same stimulation protocol as for the tVNS will be applied (30 s ON, 30s OFF, 25 Hz frequency, 250 µs pulse widths; tVNS R device, tVNS Technologies GmbH, Erlangen, Germany) and stimulation intensities will be adjusted to correspond to a mild pricking sensation.

DIAGNOSTIC_TEST

Oral glucose tolerance test (oGTT)

"The oGTT will be conducted as a standardized metabolic challenge to assess glucose metabolism and insulin sensitivity. After an overnight fast, participants ingest a 75 g glucose solution. Venous blood samples are collected at five time points (0, 30, 60, 90, and 120 minutes) to measure plasma glucose and insulin concentrations. The primary variable of interest will be the peripheral insulin sensitivity index (ISI) according to Matsuda and DeFronzo as 10,000/(G0 × I0 × Gmean × Imean)1/2 with G = glucose and I = insulin.~Additionally we will investigate the correspondence of ISI with other measures of insulin sensitivity (HOMA-IR), and Insulin secretion indices (Insulinogenic index (IGI), Corrected insulin response (CIR), Areas under the curve (AUC)), and HbA1c."

Trial Locations (1)

53127

Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn, Bonn

All Listed Sponsors
lead

University of Bonn

OTHER

NCT07198100 - tVNS, Motivation, and Insulin Sensitivity | Biotech Hunter | Biotech Hunter