Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study
To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) ent...
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| Published in | Neurology Vol. 87; no. 5; p. 529 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
02.08.2016
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| Subjects | |
| Online Access | Get more information |
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| Abstract | To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.
In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use.
Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01).
Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed.
NCT01667250.
This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS. |
|---|---|
| AbstractList | To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.
In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use.
Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01).
Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed.
NCT01667250.
This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS. |
| Author | Lipton, Richard B Grosberg, Brian M Goadsby, Peter J Silberstein, Stephen D Mullin, Chris Cady, Roger K Dorlas, Stefanie Saper, Joel R Liebler, Eric J Simmons, Kristy A Calhoun, Anne H |
| Author_xml | – sequence: 1 givenname: Stephen D surname: Silberstein fullname: Silberstein, Stephen D email: stephen.silberstein@jefferson.edu organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion. stephen.silberstein@jefferson.edu – sequence: 2 givenname: Anne H surname: Calhoun fullname: Calhoun, Anne H organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 3 givenname: Richard B surname: Lipton fullname: Lipton, Richard B organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 4 givenname: Brian M surname: Grosberg fullname: Grosberg, Brian M organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 5 givenname: Roger K surname: Cady fullname: Cady, Roger K organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 6 givenname: Stefanie surname: Dorlas fullname: Dorlas, Stefanie organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 7 givenname: Kristy A surname: Simmons fullname: Simmons, Kristy A organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 8 givenname: Chris surname: Mullin fullname: Mullin, Chris organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 9 givenname: Eric J surname: Liebler fullname: Liebler, Eric J organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 10 givenname: Peter J surname: Goadsby fullname: Goadsby, Peter J organization: From Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion – sequence: 11 givenname: Joel R surname: Saper fullname: Saper, Joel R |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27412146$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Goadsby, Peter Gelfand, Amy Silberstein, Stephen D Vollbracht, Sarah Pavlovic, Jelena Eller, Michael Cady, Roger K Da Silva, Arnaldo Weintraub, James Nahas-Geiger, Stephanie Saper, Joel Mullin, Kathleen Sinka, Erik Young, William Grosberg, Brian Robbins, Matthew Issa, Shirin Dexter, John Marmura, Michael Prestegaard, Alicia Lipton, Richard Calhoun, Anne H |
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| Copyright | 2016 American Academy of Neurology. |
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| License | 2016 American Academy of Neurology. |
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| PublicationTitle | Neurology |
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| PublicationYear | 2016 |
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| Snippet | To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.
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| SubjectTerms | Adolescent Adult Aged Double-Blind Method Female Headache Disorders - prevention & control Humans Male Middle Aged Migraine Disorders - prevention & control Pilot Projects Treatment Outcome Vagus Nerve Stimulation - adverse effects Young Adult |
| Title | Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study |
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