Amantadine to improve neurorecovery in traumatic brain injury-associated diffuse axonal injury: a pilot double-blind randomized trial
Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMD...
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| Veröffentlicht in: | The journal of head trauma rehabilitation 2002-08, Vol.17 (4), p.300-313 |
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| creator | Meythaler, Jay M Brunner, Robert C Johnson, Alice Novack, Thomas A |
| description | Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMDA) channels, amantadine has been the subject of considerable interest and clinical use in acute TBI.
In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial.
Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively.
There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (P =.0185), Disability Rating Scale (DRS) score of 9.8 points (P =.0022), Glasgow Outcome Scale (GOS) score of 0.8 points (P =.0077), and in the FIM Cognitive score (FIM-cog) of 15.1 points (P =.0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P >.05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (P =.0006), in the GOS of 0.5 points (P =.0231), and in the FIM-cog of 11.3 points (P =.0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (P =.0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (P =.0409), 3.8 points in the DRS (P =.0099), 0.5 points in the GOS (P =.4008), and 5.2 points in the FIM-cog (P =.0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug.
There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury. |
| doi_str_mv | 10.1097/00001199-200208000-00004 |
| format | Article |
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In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial.
Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively.
There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (P =.0185), Disability Rating Scale (DRS) score of 9.8 points (P =.0022), Glasgow Outcome Scale (GOS) score of 0.8 points (P =.0077), and in the FIM Cognitive score (FIM-cog) of 15.1 points (P =.0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P >.05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (P =.0006), in the GOS of 0.5 points (P =.0231), and in the FIM-cog of 11.3 points (P =.0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (P =.0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (P =.0409), 3.8 points in the DRS (P =.0099), 0.5 points in the GOS (P =.4008), and 5.2 points in the FIM-cog (P =.0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug.
There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury.</description><identifier>ISSN: 0885-9701</identifier><identifier>EISSN: 1550-509X</identifier><identifier>DOI: 10.1097/00001199-200208000-00004</identifier><identifier>PMID: 12105999</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins Ovid Technologies</publisher><subject>Accidents, Traffic ; Adolescent ; Adult ; Aged ; Amantadine - administration & dosage ; Axons - drug effects ; Axons - pathology ; Brain Injuries - diagnosis ; Brain Injuries - drug therapy ; Cross-Over Studies ; Dopamine Agents - administration & dosage ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Glasgow Coma Scale ; Humans ; Injury Severity Score ; Male ; Middle Aged ; Pilot Projects ; Probability ; Recovery of Function ; Statistics, Nonparametric ; Treatment Outcome</subject><ispartof>The journal of head trauma rehabilitation, 2002-08, Vol.17 (4), p.300-313</ispartof><rights>Copyright Aspen Publishers, Inc. Aug 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c283t-ee9412a702f50a388553e73b60a5d54a76a6871dd6d8cc2ed189098e3726588a3</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/12105999$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Meythaler, Jay M</creatorcontrib><creatorcontrib>Brunner, Robert C</creatorcontrib><creatorcontrib>Johnson, Alice</creatorcontrib><creatorcontrib>Novack, Thomas A</creatorcontrib><title>Amantadine to improve neurorecovery in traumatic brain injury-associated diffuse axonal injury: a pilot double-blind randomized trial</title><title>The journal of head trauma rehabilitation</title><addtitle>J Head Trauma Rehabil</addtitle><description>Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMDA) channels, amantadine has been the subject of considerable interest and clinical use in acute TBI.
In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial.
Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively.
There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (P =.0185), Disability Rating Scale (DRS) score of 9.8 points (P =.0022), Glasgow Outcome Scale (GOS) score of 0.8 points (P =.0077), and in the FIM Cognitive score (FIM-cog) of 15.1 points (P =.0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P >.05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (P =.0006), in the GOS of 0.5 points (P =.0231), and in the FIM-cog of 11.3 points (P =.0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (P =.0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (P =.0409), 3.8 points in the DRS (P =.0099), 0.5 points in the GOS (P =.4008), and 5.2 points in the FIM-cog (P =.0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug.
There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury.</description><subject>Accidents, Traffic</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Amantadine - administration & dosage</subject><subject>Axons - drug effects</subject><subject>Axons - pathology</subject><subject>Brain Injuries - diagnosis</subject><subject>Brain Injuries - drug therapy</subject><subject>Cross-Over Studies</subject><subject>Dopamine Agents - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Glasgow Coma Scale</subject><subject>Humans</subject><subject>Injury Severity Score</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pilot Projects</subject><subject>Probability</subject><subject>Recovery of Function</subject><subject>Statistics, Nonparametric</subject><subject>Treatment Outcome</subject><issn>0885-9701</issn><issn>1550-509X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU1rFTEUhoNY7LX6FyS4cBfNx2SSuCulfkDBTQvdDWcmZyCXmeSaTMTr3v9taq8Kns354H0OvLyEUMHfCu7MO95KCOeY5Fxy2zb2cOqekJ3QmjPN3f1TsuPWauYMF-fkeSn7xigj9DNyLqTg2jm3Iz8vV4gb-BCRbomG9ZDTN6QRa04ZpzbnIw2RbhnqCluY6Jih7SHuaz4yKCVNATb01Id5rgUpfE8RlpPgPQV6CEvaqE91XJCNS4ieZog-reFHw7YcYHlBzmZYCr489Qty9-H69uoTu_ny8fPV5Q2bpFUbQ3SdkGC4nDUH1dxphUaNPQftdQemh94a4X3v7TRJ9MI67iwqI3ttLagL8ubxb3P5tWLZhjWUCZcFIqZaBtMA1TnbhK__E-5Tzc1XGaRQTkplRRPZR9GUUykZ5-GQwwr5OAg-POQ0_Mlp-JvT71PX0Fen_3Vc0f8DT8GoX0HAj7Y</recordid><startdate>20020801</startdate><enddate>20020801</enddate><creator>Meythaler, Jay M</creator><creator>Brunner, Robert C</creator><creator>Johnson, Alice</creator><creator>Novack, Thomas A</creator><general>Lippincott Williams & Wilkins Ovid Technologies</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>8BM</scope></search><sort><creationdate>20020801</creationdate><title>Amantadine to improve neurorecovery in traumatic brain injury-associated diffuse axonal injury: a pilot double-blind randomized trial</title><author>Meythaler, Jay M ; Brunner, Robert C ; Johnson, Alice ; Novack, Thomas A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c283t-ee9412a702f50a388553e73b60a5d54a76a6871dd6d8cc2ed189098e3726588a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Accidents, Traffic</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Amantadine - administration & dosage</topic><topic>Axons - drug effects</topic><topic>Axons - pathology</topic><topic>Brain Injuries - diagnosis</topic><topic>Brain Injuries - drug therapy</topic><topic>Cross-Over Studies</topic><topic>Dopamine Agents - administration & dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Glasgow Coma Scale</topic><topic>Humans</topic><topic>Injury Severity Score</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pilot Projects</topic><topic>Probability</topic><topic>Recovery of Function</topic><topic>Statistics, Nonparametric</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Meythaler, Jay M</creatorcontrib><creatorcontrib>Brunner, Robert C</creatorcontrib><creatorcontrib>Johnson, Alice</creatorcontrib><creatorcontrib>Novack, Thomas A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>ComDisDome</collection><jtitle>The journal of head trauma rehabilitation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Meythaler, Jay M</au><au>Brunner, Robert C</au><au>Johnson, Alice</au><au>Novack, Thomas A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Amantadine to improve neurorecovery in traumatic brain injury-associated diffuse axonal injury: a pilot double-blind randomized trial</atitle><jtitle>The journal of head trauma rehabilitation</jtitle><addtitle>J Head Trauma Rehabil</addtitle><date>2002-08-01</date><risdate>2002</risdate><volume>17</volume><issue>4</issue><spage>300</spage><epage>313</epage><pages>300-313</pages><issn>0885-9701</issn><eissn>1550-509X</eissn><abstract>Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMDA) channels, amantadine has been the subject of considerable interest and clinical use in acute TBI.
In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial.
Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively.
There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (P =.0185), Disability Rating Scale (DRS) score of 9.8 points (P =.0022), Glasgow Outcome Scale (GOS) score of 0.8 points (P =.0077), and in the FIM Cognitive score (FIM-cog) of 15.1 points (P =.0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P >.05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (P =.0006), in the GOS of 0.5 points (P =.0231), and in the FIM-cog of 11.3 points (P =.0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (P =.0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (P =.0409), 3.8 points in the DRS (P =.0099), 0.5 points in the GOS (P =.4008), and 5.2 points in the FIM-cog (P =.0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug.
There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins Ovid Technologies</pub><pmid>12105999</pmid><doi>10.1097/00001199-200208000-00004</doi><tpages>14</tpages></addata></record> |
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| subjects | Accidents, Traffic Adolescent Adult Aged Amantadine - administration & dosage Axons - drug effects Axons - pathology Brain Injuries - diagnosis Brain Injuries - drug therapy Cross-Over Studies Dopamine Agents - administration & dosage Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Glasgow Coma Scale Humans Injury Severity Score Male Middle Aged Pilot Projects Probability Recovery of Function Statistics, Nonparametric Treatment Outcome |
| title | Amantadine to improve neurorecovery in traumatic brain injury-associated diffuse axonal injury: a pilot double-blind randomized trial |
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