PMID- 26631234 OWN - NLM STAT- MEDLINE DCOM- 20160518 LR - 20220330 IS - 1129-2377 (Electronic) IS - 1129-2369 (Print) IS - 1129-2369 (Linking) VI - 16 DP - 2015 TI - Cervical non-invasive vagus nerve stimulation (nVNS) for preventive and acute treatment of episodic and chronic migraine and migraine-associated sleep disturbance: a prospective observational cohort study. PG - 101 LID - 10.1186/s10194-015-0582-9 [doi] LID - 101 AB - BACKGROUND: The debilitating nature of migraine and challenges associated with treatment-refractory migraine have a profound impact on patients. With the need for alternatives to pharmacologic agents, vagus nerve stimulation has demonstrated efficacy in treatment-refractory primary headache disorders. We investigated the use of cervical non-invasive vagus nerve stimulation (nVNS) for the acute treatment and prevention of migraine attacks in treatment-refractory episodic and chronic migraine (EM and CM) and evaluated the impact of nVNS on migraine-associated sleep disturbance, disability, and depressive symptoms. METHODS: Twenty patients with treatment-refractory migraine were enrolled in this 3-month, open-label, prospective observational study. Patients administered nVNS prophylactically twice daily at prespecified times and acutely as adjunctive therapy for migraine attacks. Pain intensity (visual analogue scale [VAS]); number of headache days per month and number of migraine attacks per month; number of acutely treated attacks and time to achieve pain relief; sleep quality (Pittsburgh Sleep Quality Index [PSQI]); migraine disability assessment (MIDAS); depressive symptoms (Beck Depression Inventory((R)) [BDI]); and adverse events (AEs) were evaluated. RESULTS: Of the 20 enrolled patients, 10 patients each had been diagnosed with EM and CM. Prophylaxis with nVNS was associated with significant overall reductions in patient-perceived pain intensity (mean VAS scores at baseline vs 3 months: 7.75 +/- 0.64 vs 4.05 +/- 0.76; 95 % CI: 3.3, 4.1; p < 0.0001), mean number of headache days per month (baseline vs 3 months: 14.7 +/- 4.1 vs 8.9 +/- 3.66; 95 % CI: 3.3, 8.3; p < 0.0001), and mean number of migraine attacks per month (baseline vs 3 months: 7.3 +/- 3.85 vs 4.45 +/- 2.48; 95 % CI: 0.8, 4.9; p < 0.01). For acutely treated migraine attacks, a reduction in mean time (minutes) to achieve pain relief (baseline vs 3 months: 84.5 +/- 39.1 vs 52.75 +/- 16.42; 95 % CI: 12.6, 51.0; p < 0.002) was noted. Significant improvements, more evident in patients with EM, were noted in MIDAS and BDI scores along with a trend toward improvement in PSQI daytime dysfunction subscore (p = 0.07). No severe or serious AEs occurred. CONCLUSION: In this study, treatment with nVNS was safe and provided clinically meaningful decreases in the frequency, intensity, and duration of migraine attacks in patients with treatment-refractory migraine. Improvements in migraine-associated disability, depression, and sleep quality were also noted. FAU - Kinfe, Thomas M AU - Kinfe TM AD - Division of Functional Neurosurgery and Neuromodulation, Rheinische Friedrich-Wilhelms University, Regina-Pacis-Weg 3, 53113, Bonn, Germany. thomas.kinfe@ukb.uni-bonn.de. AD - Department of Neurosurgery, Rheinische Friedrich-Wilhelms University, Regina-Pacis-Weg 3, 53113, Bonn, Germany. thomas.kinfe@ukb.uni-bonn.de. FAU - Pintea, Bogdan AU - Pintea B AD - Department of Neurosurgery, Rheinische Friedrich-Wilhelms University, Regina-Pacis-Weg 3, 53113, Bonn, Germany. bogdan.pintea@ukb.uni-bonn.de. FAU - Muhammad, Sajjad AU - Muhammad S AD - Department of Neurosurgery, Rheinische Friedrich-Wilhelms University, Regina-Pacis-Weg 3, 53113, Bonn, Germany. sajjad.muhammad@ukb.uni-bonn.de. FAU - Zaremba, Sebastian AU - Zaremba S AD - Sleep Medicine, Department of Neurology, Rheinische Friedrich-Wilhelms University, Sigmund-Freud-Str. 25, D-53105, Bonn, Germany. sebastian.zaremba@ukb.uni-bonn.de. AD - Department of Clinical Research, German Centre for Neurodegenerative Diseases (DZNE), Ernst-Robert-Curtius-Str. 12, 53117, Bonn, Germany. sebastian.zaremba@ukb.uni-bonn.de. FAU - Roeske, Sandra AU - Roeske S AD - Department of Clinical Research, German Centre for Neurodegenerative Diseases (DZNE), Ernst-Robert-Curtius-Str. 12, 53117, Bonn, Germany. sandra.roeske@dzne.de201. FAU - Simon, Bruce J AU - Simon BJ AD - electroCore, LLC, 150 Allen Road, Suite 201, Basking Ridge, NJ, 07920, USA. bruce.simon@electrocorellc.com. FAU - Vatter, Hartmut AU - Vatter H AD - Department of Neurosurgery, Rheinische Friedrich-Wilhelms University, Regina-Pacis-Weg 3, 53113, Bonn, Germany. hartmut.vatter@ukb.uni-bonn.de. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20151203 PL - England TA - J Headache Pain JT - The journal of headache and pain JID - 100940562 SB - IM MH - Adult MH - Aged MH - Cervical Vertebrae MH - Chronic Disease MH - Cohort Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - Migraine Disorders/*epidemiology/*prevention & control MH - Pain Measurement/*methods MH - Prospective Studies MH - Sleep Wake Disorders/*epidemiology/*prevention & control MH - Treatment Outcome MH - Vagus Nerve Stimulation/*methods PMC - PMC4668248 OTO - NOTNLM OT - Acute therapy OT - Headache OT - Neuromodulation OT - Prophylactic therapy OT - Sleep impairment EDAT- 2015/12/04 06:00 MHDA- 2016/05/19 06:00 PMCR- 2015/12/03 CRDT- 2015/12/04 06:00 PHST- 2015/10/23 00:00 [received] PHST- 2015/11/19 00:00 [accepted] PHST- 2015/12/04 06:00 [entrez] PHST- 2015/12/04 06:00 [pubmed] PHST- 2016/05/19 06:00 [medline] PHST- 2015/12/03 00:00 [pmc-release] AID - 10.1186/s10194-015-0582-9 [pii] AID - 582 [pii] AID - 10.1186/s10194-015-0582-9 [doi] PST - ppublish SO - J Headache Pain. 2015;16:101. doi: 10.1186/s10194-015-0582-9. Epub 2015 Dec 3.