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Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial
Summary Background Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomise...
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Published in: | Lancet neurology 2010-04, Vol.9 (4), p.373-380 |
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creator | Lipton, Richard B, MD Dodick, David W, MD Silberstein, Stephen D, MD Saper, Joel R, MD Aurora, Sheena K, MD Pearlman, Starr H, PhD Fischell, Robert E, ScD Ruppel, Patricia L, MPH Goadsby, Peter J, MD |
description | Summary Background Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18–68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov , number NCT00449540. Findings 37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3–31%; p=0·0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups. Interpretation Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura. Funding Neuralieve. |
doi_str_mv | 10.1016/S1474-4422(10)70054-5 |
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We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18–68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov , number NCT00449540. Findings 37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3–31%; p=0·0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups. Interpretation Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura. Funding Neuralieve.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(10)70054-5</identifier><identifier>PMID: 20206581</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Double-Blind Method ; Female ; Headaches ; Humans ; Magnetic fields ; Male ; Middle Aged ; Migraine ; Migraine with Aura - therapy ; Neurology ; Pain ; Pain Management ; Response rates ; Time Factors ; Transcranial magnetic stimulation ; Transcranial Magnetic Stimulation - adverse effects ; Transcranial Magnetic Stimulation - methods ; Treatment Outcome ; United States ; Visual Perception ; Young Adult</subject><ispartof>Lancet neurology, 2010-04, Vol.9 (4), p.373-380</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Apr 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c504t-a0af6cb8bb711b3f56993d88790955ca91e5bfc7639cf3913fd3da2e66fa8a03</citedby><cites>FETCH-LOGICAL-c504t-a0af6cb8bb711b3f56993d88790955ca91e5bfc7639cf3913fd3da2e66fa8a03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20206581$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lipton, Richard B, MD</creatorcontrib><creatorcontrib>Dodick, David W, MD</creatorcontrib><creatorcontrib>Silberstein, Stephen D, MD</creatorcontrib><creatorcontrib>Saper, Joel R, MD</creatorcontrib><creatorcontrib>Aurora, Sheena K, MD</creatorcontrib><creatorcontrib>Pearlman, Starr H, PhD</creatorcontrib><creatorcontrib>Fischell, Robert E, ScD</creatorcontrib><creatorcontrib>Ruppel, Patricia L, MPH</creatorcontrib><creatorcontrib>Goadsby, Peter J, MD</creatorcontrib><title>Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>Summary Background Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18–68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov , number NCT00449540. Findings 37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3–31%; p=0·0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups. Interpretation Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura. Funding Neuralieve.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Headaches</subject><subject>Humans</subject><subject>Magnetic fields</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Migraine</subject><subject>Migraine with Aura - therapy</subject><subject>Neurology</subject><subject>Pain</subject><subject>Pain Management</subject><subject>Response rates</subject><subject>Time Factors</subject><subject>Transcranial magnetic stimulation</subject><subject>Transcranial Magnetic Stimulation - adverse effects</subject><subject>Transcranial Magnetic Stimulation - methods</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Visual Perception</subject><subject>Young Adult</subject><issn>1474-4422</issn><issn>1474-4465</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNqFkctu1TAQhiMEoqXwCCCLDSA14EucCwtQVXGTKrFo99bEmZy6OHawHVCfhZetc87hLLrpxpfR72_-8V8ULxl9zyirP1yyqqnKquL8LaPvGkplVcpHxfG-XMvHhzPnR8WzGG8o5axq2dPiiFNOa9my4-LfpXEbi-W82IgkBXBR58WAJRNsHCajSUxmWiwk4x0ZfSCgl7RqEdKELhE_kslsAhiH5K9J1wSWAB8JkAwa_GQiDqdk8Euf-_TWuHybIYC1aMtN8Mt8SuI1TKX2LgWfy0OGZwfPiycjZFsv9vtJcfX1y9X59_Li57cf52cXpZa0SiVQGGvdt33fMNaLUdZdJ4a2bTraSamhYyj7UTe16PQoOibGQQzAsa5HaIGKk-LNDjsH_3vBmFS2rNFacOiXqJqqpk3Hqu5hpRAtbdtaZuXre8obvwSXp1Cc5lg4FStO7kQ6-BgDjmoOZoJwqxhVa8hqG7JaE1xL25DVCn-1hy_9hMPh1f9Us-DzToD51_4YDCpqg07jYALqpAZvHmzx6R5B5-CMBvsLbzEehmEqckV3kJXB6JYgxR0DI83X</recordid><startdate>20100401</startdate><enddate>20100401</enddate><creator>Lipton, Richard B, MD</creator><creator>Dodick, David W, MD</creator><creator>Silberstein, Stephen D, MD</creator><creator>Saper, Joel R, MD</creator><creator>Aurora, Sheena K, MD</creator><creator>Pearlman, Starr H, PhD</creator><creator>Fischell, Robert E, ScD</creator><creator>Ruppel, Patricia L, MPH</creator><creator>Goadsby, Peter J, MD</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20100401</creationdate><title>Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial</title><author>Lipton, Richard B, MD ; Dodick, David W, MD ; Silberstein, Stephen D, MD ; Saper, Joel R, MD ; Aurora, Sheena K, MD ; Pearlman, Starr H, PhD ; Fischell, Robert E, ScD ; Ruppel, Patricia L, MPH ; Goadsby, Peter J, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c504t-a0af6cb8bb711b3f56993d88790955ca91e5bfc7639cf3913fd3da2e66fa8a03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Headaches</topic><topic>Humans</topic><topic>Magnetic fields</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Migraine</topic><topic>Migraine with Aura - 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Academic</collection><jtitle>Lancet neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lipton, Richard B, MD</au><au>Dodick, David W, MD</au><au>Silberstein, Stephen D, MD</au><au>Saper, Joel R, MD</au><au>Aurora, Sheena K, MD</au><au>Pearlman, Starr H, PhD</au><au>Fischell, Robert E, ScD</au><au>Ruppel, Patricia L, MPH</au><au>Goadsby, Peter J, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial</atitle><jtitle>Lancet neurology</jtitle><addtitle>Lancet Neurol</addtitle><date>2010-04-01</date><risdate>2010</risdate><volume>9</volume><issue>4</issue><spage>373</spage><epage>380</epage><pages>373-380</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><coden>LANCAO</coden><abstract>Summary Background Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura. Methods We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA. 267 adults aged 18–68 years were enrolled into phase one. All individuals had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. 66 patients dropped out during phase one. In phase two, 201 individuals were randomly allocated by computer to either sham stimulation (n=99) or sTMS (n=102). We instructed participants to treat up to three attacks over 3 months while experiencing aura. The primary outcome was pain-free response 2 h after the first attack, and co-primary outcomes were non-inferiority at 2 h for nausea, photophobia, and phonophobia. Analyses were modified intention to treat and per protocol. This trial is registered with ClinicalTrials.gov , number NCT00449540. Findings 37 patients did not treat a migraine attack and were excluded from outcome analyses. 164 patients treated at least one attack with sTMS (n=82) or sham stimulation (n=82; modified intention-to-treat analysis set). Pain-free response rates after 2 h were significantly higher with sTMS (32/82 [39%]) than with sham stimulation (18/82 [22%]), for a therapeutic gain of 17% (95% CI 3–31%; p=0·0179). Sustained pain-free response rates significantly favoured sTMS at 24 h and 48 h post-treatment. Non-inferiority was shown for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and incidence and severity of adverse events were similar between sTMS and sham groups. Interpretation Early treatment of migraine with aura by sTMS resulted in increased freedom from pain at 2 h compared with sham stimulation, and absence of pain was sustained 24 h and 48 h after treatment. sTMS could be a promising acute treatment for some patients with migraine with aura. Funding Neuralieve.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>20206581</pmid><doi>10.1016/S1474-4422(10)70054-5</doi><tpages>8</tpages></addata></record> |
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subjects | Adolescent Adult Aged Double-Blind Method Female Headaches Humans Magnetic fields Male Middle Aged Migraine Migraine with Aura - therapy Neurology Pain Pain Management Response rates Time Factors Transcranial magnetic stimulation Transcranial Magnetic Stimulation - adverse effects Transcranial Magnetic Stimulation - methods Treatment Outcome United States Visual Perception Young Adult |
title | Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial |
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