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NeuroMSleepModeD Neuromodulation in patients with early stage depression and sleeping disturbances as well as multiple sclerosis

NeuroMSleepModeD Neuromodulation in patients with early stage depression and sleeping disturbances as well as multiple sclerosis - NeuroMSleepModeD

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040782
Enrollment
60
Registered
2026-07-16
Start date
2025-04-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

F32.0 F32.1 F32.8 G35

Interventions

Group 1: Patients with mild to moderate early-stage depressive symptoms, four-week treatment with transcutaneous vagus nerve stimulation

Sponsors

Edda und Helmut Laich Stiftung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: • Mild to moderate depressive symptoms, acute depressive episode (including sleep disturbances) • (MS diagnosis) • If applicable, diagnosis of depression for no more than 4 years

Exclusion criteria

Exclusion criteria: • Use of psychiatric medications or sedative sleep aids • Severe visual impairment • Severe physical or other psychiatric conditions • Alcohol or drug dependence • Metal objects that are not compatible with MRI scans

Design outcomes

Primary

MeasureTime frame
Change in depressive symptoms (External assessment using the Hamilton Depression Rating Scale weekly at t0, t1, t2, t3, and t4, t5; self-assessment using the BDI-II every two weeks at t0, t2, and t4, t5)

Secondary

MeasureTime frame
cortical activation, functional connectivity, sleep quality, quality of life, immune parameters

Countries

Germany

Contacts

Public ContactFelix Bernhard

Klinik für Psychiatrie und Psychotherapie Philipps-Universität Marburg

felix.bernhard@staff.uni-marburg.de+49(0)64215861843

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026