Abstract
Background: Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine. Methods: Fifty-six enrolled subjects (menstrual migraine, 9%; menstrually related migraine, 91%), 33 (59%) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61%) or as monotherapy (20/51; 39%) on day −3 before estimated onset of menses through day +3 after the end of menses. Results: The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7days) to the end of treatment (mean ± standard error, 4.7 ± 0.5days; P < 0.001) (primary end point). Of all subjects, 39% (95% confidence interval: 26%, 54%) (20/51) had a ≥ 50% reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns. Conclusions: These findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.
| Original language | English |
|---|---|
| Article number | 91 |
| Journal | Journal of Headache and Pain |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Dec 1 2016 |
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Keywords
- Menstrual migraine
- Menstrually related migraine
- Prophylactic treatment
- Vagus nerve
ASJC Scopus subject areas
- Clinical Neurology
- Anesthesiology and Pain Medicine
Cite this
Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine : An open-label study. / Grazzi, Licia; Egeo, Gabriella; Calhoun, Anne H.; McClure, Candace K.; Liebler, Eric; Barbanti, Piero.
In: Journal of Headache and Pain, Vol. 17, No. 1, 91, 01.12.2016.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine
T2 - An open-label study
AU - Grazzi, Licia
AU - Egeo, Gabriella
AU - Calhoun, Anne H.
AU - McClure, Candace K.
AU - Liebler, Eric
AU - Barbanti, Piero
PY - 2016/12/1
Y1 - 2016/12/1
N2 - Background: Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine. Methods: Fifty-six enrolled subjects (menstrual migraine, 9%; menstrually related migraine, 91%), 33 (59%) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61%) or as monotherapy (20/51; 39%) on day −3 before estimated onset of menses through day +3 after the end of menses. Results: The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7days) to the end of treatment (mean ± standard error, 4.7 ± 0.5days; P < 0.001) (primary end point). Of all subjects, 39% (95% confidence interval: 26%, 54%) (20/51) had a ≥ 50% reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns. Conclusions: These findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.
AB - Background: Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine. Methods: Fifty-six enrolled subjects (menstrual migraine, 9%; menstrually related migraine, 91%), 33 (59%) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61%) or as monotherapy (20/51; 39%) on day −3 before estimated onset of menses through day +3 after the end of menses. Results: The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7days) to the end of treatment (mean ± standard error, 4.7 ± 0.5days; P < 0.001) (primary end point). Of all subjects, 39% (95% confidence interval: 26%, 54%) (20/51) had a ≥ 50% reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns. Conclusions: These findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.
KW - Menstrual migraine
KW - Menstrually related migraine
KW - Prophylactic treatment
KW - Vagus nerve
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UR - http://www.scopus.com/inward/citedby.url?scp=84989953094&partnerID=8YFLogxK
U2 - 10.1186/s10194-016-0684-z
DO - 10.1186/s10194-016-0684-z
M3 - Article
VL - 17
JO - Journal of Headache and Pain
JF - Journal of Headache and Pain
SN - 1129-2369
IS - 1
M1 - 91
ER -