Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial
To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1 ) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigat...
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| creator | Edwards, Dylan J Liu, Charles Y Dunning, Kari Fregni, Felipe Laine, Jarmo Leiby, Benjamin E Rogers, Lynn M Harvey, Richard L |
| description | To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1
) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil.
The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1
, preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety.
Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D ( |
| doi_str_mv | 10.1161/STROKEAHA.123.043164 |
| format | Article |
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) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil.
The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1
, preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety.
Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D (
<0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group (
=0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group,
=0.72).
Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent.
URL: https://www.
gov; Unique identifier: NCT03010462.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.123.043164</identifier><identifier>PMID: 37577801</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Bayes Theorem ; Clinical Trials ; Humans ; Quality of Life ; Recovery of Function ; Stroke - complications ; Stroke - therapy ; Stroke Rehabilitation - methods ; Transcranial Magnetic Stimulation - methods ; Treatment Outcome ; Upper Extremity</subject><ispartof>Stroke (1970), 2023-09, Vol.54 (9), p.2254-2264</ispartof><rights>2023 The Authors. 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-2320f8c37df360daede220474111280c5930252a0683786fc124feec8399a9213</citedby><cites>FETCH-LOGICAL-c409t-2320f8c37df360daede220474111280c5930252a0683786fc124feec8399a9213</cites><orcidid>0000-0001-6423-8577 ; 0000-0001-6763-169X ; 0000-0001-7346-3100 ; 0000-0003-0761-8383</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37577801$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Edwards, Dylan J</creatorcontrib><creatorcontrib>Liu, Charles Y</creatorcontrib><creatorcontrib>Dunning, Kari</creatorcontrib><creatorcontrib>Fregni, Felipe</creatorcontrib><creatorcontrib>Laine, Jarmo</creatorcontrib><creatorcontrib>Leiby, Benjamin E</creatorcontrib><creatorcontrib>Rogers, Lynn M</creatorcontrib><creatorcontrib>Harvey, Richard L</creatorcontrib><title>Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1
) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil.
The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1
, preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety.
Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D (
<0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group (
=0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group,
=0.72).
Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent.
URL: https://www.
gov; Unique identifier: NCT03010462.</description><subject>Bayes Theorem</subject><subject>Clinical Trials</subject><subject>Humans</subject><subject>Quality of Life</subject><subject>Recovery of Function</subject><subject>Stroke - complications</subject><subject>Stroke - therapy</subject><subject>Stroke Rehabilitation - methods</subject><subject>Transcranial Magnetic Stimulation - methods</subject><subject>Treatment Outcome</subject><subject>Upper Extremity</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkVtPGzEQha2qqATKP6gqP_Zlw_iyu96-oChKCOJWheXZcr2zwa0Tg72JBL-ejQIRPM1o5pwzI32E_GAwZKxgp3f1_PZyMpqNhoyLIUjBCvmFDFjOZSYLrr6SAYCoMi6r6pAcpfQPALhQ-TdyKMq8LBWwAVlMPNouOkunDn1Db8zGLUyHDWXZ7IXG-vqOtiHSPyF1qYvhP9Lr0PWDOdqwwfj8m9YPSCfZ9KKmc7NqwtK99O5xWPVq7_u2js747-SgNT7hyVs9JvfTST2eZVe35xfj0VVmJVRdxgWHVllRNq0ooDHYIOcgS8kY4wpsXgngOTdQKFGqorWMyxbRKlFVpuJMHJOzXe7j-u8SG4v9G8brx-iWJj7rYJz-vFm5B70IG81A5kLk24RfbwkxPK0xdXrpkkXvzQrDOmmucihZKWArlTupjSGliO3-DgO9haT3kHQPSe8g9bafH3_cm96piFfqA41Q</recordid><startdate>20230901</startdate><enddate>20230901</enddate><creator>Edwards, Dylan J</creator><creator>Liu, Charles Y</creator><creator>Dunning, Kari</creator><creator>Fregni, Felipe</creator><creator>Laine, Jarmo</creator><creator>Leiby, Benjamin E</creator><creator>Rogers, Lynn M</creator><creator>Harvey, Richard L</creator><general>Lippincott Williams & Wilkins</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>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6423-8577</orcidid><orcidid>https://orcid.org/0000-0001-6763-169X</orcidid><orcidid>https://orcid.org/0000-0001-7346-3100</orcidid><orcidid>https://orcid.org/0000-0003-0761-8383</orcidid></search><sort><creationdate>20230901</creationdate><title>Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial</title><author>Edwards, Dylan J ; Liu, Charles Y ; Dunning, Kari ; Fregni, Felipe ; Laine, Jarmo ; Leiby, Benjamin E ; Rogers, Lynn M ; Harvey, Richard L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-2320f8c37df360daede220474111280c5930252a0683786fc124feec8399a9213</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Bayes Theorem</topic><topic>Clinical Trials</topic><topic>Humans</topic><topic>Quality of Life</topic><topic>Recovery of Function</topic><topic>Stroke - complications</topic><topic>Stroke - therapy</topic><topic>Stroke Rehabilitation - methods</topic><topic>Transcranial Magnetic Stimulation - methods</topic><topic>Treatment Outcome</topic><topic>Upper Extremity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Edwards, Dylan J</creatorcontrib><creatorcontrib>Liu, Charles Y</creatorcontrib><creatorcontrib>Dunning, Kari</creatorcontrib><creatorcontrib>Fregni, Felipe</creatorcontrib><creatorcontrib>Laine, Jarmo</creatorcontrib><creatorcontrib>Leiby, Benjamin E</creatorcontrib><creatorcontrib>Rogers, Lynn M</creatorcontrib><creatorcontrib>Harvey, Richard L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Edwards, Dylan J</au><au>Liu, Charles Y</au><au>Dunning, Kari</au><au>Fregni, Felipe</au><au>Laine, Jarmo</au><au>Leiby, Benjamin E</au><au>Rogers, Lynn M</au><au>Harvey, Richard L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2023-09-01</date><risdate>2023</risdate><volume>54</volume><issue>9</issue><spage>2254</spage><epage>2264</epage><pages>2254-2264</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><abstract>To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1
) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil.
The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1
, preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety.
Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D (
<0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group (
=0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group,
=0.72).
Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent.
URL: https://www.
gov; Unique identifier: NCT03010462.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>37577801</pmid><doi>10.1161/STROKEAHA.123.043164</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-6423-8577</orcidid><orcidid>https://orcid.org/0000-0001-6763-169X</orcidid><orcidid>https://orcid.org/0000-0001-7346-3100</orcidid><orcidid>https://orcid.org/0000-0003-0761-8383</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Stroke (1970), 2023-09, Vol.54 (9), p.2254-2264 |
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| language | eng |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Journals@Ovid Complete |
| subjects | Bayes Theorem Clinical Trials Humans Quality of Life Recovery of Function Stroke - complications Stroke - therapy Stroke Rehabilitation - methods Transcranial Magnetic Stimulation - methods Treatment Outcome Upper Extremity |
| title | Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial |
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