Saliva molecular inflammatory profiling in female migraine patients responsive to adjunctive cervical non-invasive vagus nerve stimulation: the MOXY Study.

Abstract

BACKGROUND:

Rising evidence indicate that oxytocin and IL-1β impact trigemino-nociceptive signaling. Current perspectives on migraine physiopathology emphasize a cytokine bias towards a pro-inflammatory status. The anti-nociceptive impact of oxytocin has been reported in preclinical and human trials. Cervical non-invasive vagus nerve stimulation (nVNS) emerges as an add-on treatment for the preventive and abortive use in migraine. Less is known about its potential to modulate saliva inflammatory signaling in migraine patients. The rationale was to perform inter-ictal saliva measures of oxytocin and IL-1ß along with headache assessment in migraine patients with 10 weeks adjunctive nVNS compared to healthy controls.

METHODS:

12 migraineurs and 12 suitably matched healthy control were studied with inter-ictal saliva assay of pro- and anti-neuroinflammatory cytokines using enzyme-linked immuno assay techniques along with assessment of headache severity/frequency and associated functional capacity at baseline and after 10 weeks adjunctive cervical nVNS.

RESULTS:

nVNS significantly reduced headache severity (VAS), frequency (headache days and total number of attacks) and significantly improved sleep quality compared to baseline (p < 0.01). Inter-ictal saliva oxytocin and IL-1β were significantly elevated pre- as well as post-nVNS compared to healthy controls (p < 0.01) and similarly showed changes that may reflect the observed clinical effects.

CONCLUSIONS:

Our results add to accumulating evidence for a therapeutic efficacy of adjunct cervical non-invasive vagus nerve stimulation in migraine patients. This study failed to provide an evidence-derived conclusion addressed to the predictive value and usefulness of saliva assays due to its uncontrolled study design. However, saliva screening of mediators associated with trigemino-nociceptive traffic represents a novel approach, thus deserve future targeted headache research. Trial registration This study was indexed at the German Register for Clinical Trials (DRKS No. 00011089) registered on 21.09.2016.

• Authors: Azize Boström, Dirk Scheele, Birgit Stoffel-Wagner, Frigga Hönig, Shafqat R Chaudhry, Sajjad Muhammad, Rene Hurlemann, Joachim K Krauss, Ilana S Lendvai, Krishnan V Chakravarthy, Thomas M Kinfe
• Journal: Journal of translational medicine (J Transl Med) Vol. 17 Issue 1 Pg. 53 (02 22 2019) ISSN: 1479-5876 [Electronic] England
• PMID: 30795781 (Publication Type: Clinical Trial, Journal Article, Observational Study)

Chemical References

• IL1B protein, human
• Interleukin-1beta
• Oxytocin

Topics

• Adult
• Aged
• Cervical Vertebrae (innervation)
• Depression (etiology)
• Female
• Humans
• Inflammation (pathology)
• Interleukin-1beta (metabolism)
• Middle Aged
• Migraine Disorders (complications, physiopathology, therapy)
• Oxytocin (metabolism)
• Pain
• Quality of Life
• Saliva (metabolism)
• Sleep (physiology)
• Vagus Nerve Stimulation (adverse effects)