Assessment of non-invasive vagal nerve Stimulation (VNS)-induced head pain-effects in refractory migraine patients: a multimodal fMRI study

Assessment of non-invasive vagal nerve Stimulation (VNS)-induced head pain-effects in refractory migraine patients: a multimodal fMRI study - nVNS fMRT refractory migraine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009944

Enrollment

Registered

2016-02-08

Start date

2016-04-15

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Migraine R51 G43

Interventions

Group 1: Arm 1 Cervical non-invasive vagal nerve Stimulation nVNS In the project proposed here, the effects of (25Hz to 5000Hz Burst) nVNS will be investigated in migraine patients for structural and

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: - Male / Female subjects - Right-handedness - Oral and written informed consent - Stable headache medication 4 weeks prior to study entry - Refractory to drug / behavior therapy / psychiatric therapies -confirmed diagnosis according to IHCD-3 beta -Willing to fullfil follow-up investigations

Exclusion criteria

Exclusion criteria: - Neurological diseases, current and / or history (including severe craniocerebral trauma.) - Abuse or dependence of analgesic / psychotropic substances including alcohol (except nicotine) in the history or current - Severe psychiatric disorders in history and currently, serious physical disorders, especially unstable cardiovascular disorders - Claustrophobia - Non-removable ferromagnetic metallic implants, probes, stimulators, prostheses, pacemakers, large tattoos, etc. - Age 60 years - Neuromodulation treatment in prehistory

Design outcomes

Primary

Measure	Time frame
After performing an MRI baseline examination (rsfMRT, pCASL, VBM, DTI), blood sample collection and clinical head pain assessment, migraineurs will receive either verum chronic nVNS (25Hz to 5000Hz Burst) 2 times a day with 120 seconds duration (prevention) and at the beginning of migraine attacks on both sides in each case with cervical 120 seconds (acute treatment), while the other group receive placebo stimulation (in addition healthy individuals will serve as control group) over an identical time scheme over a period of 8 weeks. After 8 weeks, patients are clinically evaluated (pain assessment, see Appendix), blood samples collected along with a follow-up MRI examination (rsfMRT, pCASL, VBM, DTI) in order to detect possible effects of nVNS on structural and functional parameters in the brain and compared to the effects of a Sham-stimulation and healthy controls. 40 migraine patients will be enrolled and randomized to verum versus sham VNS treatment for 8 weeks (20 verum nVNS+sham nVNS). Migraine-associated co-morbidities and funtional outcome will be measured using MIDAS, BDI and PSQI. In Addition intensitiy and frequency of headache will be recorded. In addition a healthy control group of 20 individuals will receive fMRI scans at baseline and after 8 weeks in order to investigate migraine-specific structural and functional brain structure changes	—

Measure

Time frame

After performing an MRI baseline examination (rsfMRT, pCASL, VBM, DTI), blood sample collection and clinical head pain assessment, migraineurs will receive either verum chronic nVNS (25Hz to 5000Hz Burst) 2 times a day with 120 seconds duration (prevention) and at the beginning of migraine attacks on both sides in each case with cervical 120 seconds (acute treatment), while the other group receive placebo stimulation (in addition healthy individuals will serve as control group) over an identical time scheme over a period of 8 weeks. After 8 weeks, patients are clinically evaluated (pain assessment, see Appendix), blood samples collected along with a follow-up MRI examination (rsfMRT, pCASL, VBM, DTI) in order to detect possible effects of nVNS on structural and functional parameters in the brain and compared to the effects of a Sham-stimulation and healthy controls. 40 migraine patients will be enrolled and randomized to verum versus sham VNS treatment for 8 weeks (20 verum nVNS+sham nVNS). Migraine-associated co-morbidities and funtional outcome will be measured using MIDAS, BDI and PSQI. In Addition intensitiy and frequency of headache will be recorded. In addition a healthy control group of 20 individuals will receive fMRI scans at baseline and after 8 weeks in order to investigate migraine-specific structural and functional brain structure changes

—

Secondary

Measure	Time frame
Correlation between clinical assessment (through interview and patient's headache diary), fMRI findings and the changes in cytokine plasma levels (ELISA) for pro- and anti-inflammatory Mediators before and after 8 weeks VNS treatment (Adiponectin, Ghrelin, HMGB1, Interleukin-1, Interleukin-6, Interleukin-10, Leptin, TNF).	—

Countries

Germany

Contacts

Public ContactThomas M. Kinfe

Funktionelle Neurochirurgie, Stereotaxie und Neuromodulation, Klinik für Neurochirurgie

thomas.kinfe@ukb.uni-bonn.de+49 (0)228 287 - 13812

Outcome results

None listed

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