fMRI of Language Recovery Following Stroke in Adults
10 de maio de 2018 atualizado por: Jerzy P Szaflarski, University of Alabama at Birmingham
The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.
Visão geral do estudo
Descrição detalhada
Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke.
Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke.
In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT.
The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.
Tipo de estudo
Intervencional
Inscrição (Real)
24
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
19 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
- Moderate aphasia (Token Test score between 40th and 90th percentile)
- Written informed consent by the patient or the next of kin
Exclusion Criteria:
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Pregnancy
- Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Aphasia - CIAT
Patients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT
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Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day.
Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
Outros nomes:
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Sem intervenção: Aphasia - observation
Patients with aphasia >1 year after left MCA stroke who will be randomized to no intervention (observation)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Primary outcome measure is aphasia improvement.
Prazo: 1 week and 3 months after intervention
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The Token Test was used only for primary screening and study qualification.
All participants received NAT which included: (1) the Boston Naming Test (BNT) (Kaplan, Goodglass et al. 1983), (2) the Controlled Oral Word Association Test (Lezak 1995), (3) the Semantic Fluency Test (SFT) (Kozora and Cullum 1995, Lezak 1995), (4) the Complex Ideation subtest from the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass and Kaplan 1972), (5) the Peabody Picture Vocabulary Test III (PPVT III) (Dunn and Dunn 1997), and (6) the Mini-Communicative Activities Log (Mini-CAL) which is a subjective measure of communicative abilities (Pulvermuller, Neininger et al. 2001, Szaflarski, Ball et al. 2008).
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1 week and 3 months after intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jerzy P. Szaflarski, MD, PhD, University of Alabama at Birmingham, Department of Neurology
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Pulvermuller F, Neininger B, Elbert T, Mohr B, Rockstroh B, Koebbel P, Taub E. Constraint-induced therapy of chronic aphasia after stroke. Stroke. 2001 Jul;32(7):1621-6. doi: 10.1161/01.str.32.7.1621.
- Saur D, Lange R, Baumgaertner A, Schraknepper V, Willmes K, Rijntjes M, Weiller C. Dynamics of language reorganization after stroke. Brain. 2006 Jun;129(Pt 6):1371-84. doi: 10.1093/brain/awl090. Epub 2006 Apr 25.
- Binder JR, Rao SM, Hammeke TA, Frost JA, Bandettini PA, Jesmanowicz A, Hyde JS. Lateralized human brain language systems demonstrated by task subtraction functional magnetic resonance imaging. Arch Neurol. 1995 Jun;52(6):593-601. doi: 10.1001/archneur.1995.00540300067015.
- Booth JR, MacWhinney B, Thulborn KR, Sacco K, Voyvodic JT, Feldman HM. Developmental and lesion effects in brain activation during sentence comprehension and mental rotation. Dev Neuropsychol. 2000;18(2):139-69. doi: 10.1207/S15326942DN1802_1.
- Borod JC, Carper M, Naeser M, Goodglass H. Left-handed and right-handed aphasics with left hemisphere lesions compared on nonverbal performance measures. Cortex. 1985 Mar;21(1):81-90. doi: 10.1016/s0010-9452(85)80017-4.
- Breier JI, Hasan KM, Zhang W, Men D, Papanicolaou AC. Language dysfunction after stroke and damage to white matter tracts evaluated using diffusion tensor imaging. AJNR Am J Neuroradiol. 2008 Mar;29(3):483-7. doi: 10.3174/ajnr.A0846. Epub 2007 Nov 26.
- Cao Y, Vikingstad EM, George KP, Johnson AF, Welch KM. Cortical language activation in stroke patients recovering from aphasia with functional MRI. Stroke. 1999 Nov;30(11):2331-40. doi: 10.1161/01.str.30.11.2331.
- Carlomagno S, Pandolfi M, Labruna L, Colombo A, Razzano C. Recovery from moderate aphasia in the first year poststroke: effect of type of therapy. Arch Phys Med Rehabil. 2001 Aug;82(8):1073-80. doi: 10.1053/apmr.2001.25155.
- Geschwind N, Galaburda AM. Cerebral lateralization. Biological mechanisms, associations, and pathology: I. A hypothesis and a program for research. Arch Neurol. 1985 May;42(5):428-59. doi: 10.1001/archneur.1985.04060050026008. No abstract available.
- Hillis AE, Kleinman JT, Newhart M, Heidler-Gary J, Gottesman R, Barker PB, Aldrich E, Llinas R, Wityk R, Chaudhry P. Restoring cerebral blood flow reveals neural regions critical for naming. J Neurosci. 2006 Aug 2;26(31):8069-73. doi: 10.1523/JNEUROSCI.2088-06.2006.
- Jacola LM, Schapiro MB, Schmithorst VJ, Byars AW, Strawsburg RH, Szaflarski JP, Plante E, Holland SK. Functional magnetic resonance imaging reveals atypical language organization in children following perinatal left middle cerebral artery stroke. Neuropediatrics. 2006 Feb;37(1):46-52. doi: 10.1055/s-2006-923934.
- Lee RG, van Donkelaar P. Mechanisms underlying functional recovery following stroke. Can J Neurol Sci. 1995 Nov;22(4):257-63. doi: 10.1017/s0317167100039445.
- Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
- Meinzer M, Elbert T, Wienbruch C, Djundja D, Barthel G, Rockstroh B. Intensive language training enhances brain plasticity in chronic aphasia. BMC Biol. 2004 Aug 25;2:20. doi: 10.1186/1741-7007-2-20.
- Muller RA, Rothermel RD, Behen ME, Muzik O, Chakraborty PK, Chugani HT. Language organization in patients with early and late left-hemisphere lesion: a PET study. Neuropsychologia. 1999 May;37(5):545-57. doi: 10.1016/s0028-3932(98)00109-2.
- Muller RA, Rothermel RD, Behen ME, Muzik O, Mangner TJ, Chugani HT. Differential patterns of language and motor reorganization following early left hemisphere lesion: a PET study. Arch Neurol. 1998 Aug;55(8):1113-9. doi: 10.1001/archneur.55.8.1113.
- Naeser MA, Borod JC. Aphasia in left-handers: lesion site, lesion side, and hemispheric asymmetries on CT. Neurology. 1986 Apr;36(4):471-88. doi: 10.1212/wnl.36.4.471.
- Poeck K, Huber W, Willmes K. Outcome of intensive language treatment in aphasia. J Speech Hear Disord. 1989 Aug;54(3):471-9. doi: 10.1044/jshd.5403.471.
- Sarno MT, Levita E. Recovery in treated aphasia in the first year post-stroke. Stroke. 1979 Nov-Dec;10(6):663-70. doi: 10.1161/01.str.10.6.663.
- Szaflarski JP, Ball A, Grether S, Al-Fwaress F, Griffith NM, Neils-Strunjas J, Newmeyer A, Reichhardt R. Constraint-induced aphasia therapy stimulates language recovery in patients with chronic aphasia after ischemic stroke. Med Sci Monit. 2008 May;14(5):CR243-250.
- Szaflarski JP, Binder JR, Possing ET, McKiernan KA, Ward BD, Hammeke TA. Language lateralization in left-handed and ambidextrous people: fMRI data. Neurology. 2002 Jul 23;59(2):238-44. doi: 10.1212/wnl.59.2.238.
- Taub E, Uswatte G, Morris DM. Improved motor recovery after stroke and massive cortical reorganization following Constraint-Induced Movement therapy. Phys Med Rehabil Clin N Am. 2003 Feb;14(1 Suppl):S77-91, ix. doi: 10.1016/s1047-9651(02)00052-9.
- Tillema JM, Byars AW, Jacola LM, Schapiro MB, Schmithorst VJ, Szaflarski JP, Holland SK. Cortical reorganization of language functioning following perinatal left MCA stroke. Brain Lang. 2008 May;105(2):99-111. doi: 10.1016/j.bandl.2007.07.127. Epub 2007 Oct 1.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2008
Conclusão Primária (Real)
1 de agosto de 2015
Conclusão do estudo (Real)
1 de agosto de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
12 de fevereiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de fevereiro de 2009
Primeira postagem (Estimativa)
13 de fevereiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01NS048281 (Concessão/Contrato do NIH dos EUA)
- 1R01NS048281-01A2 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em CIAT
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NRZ Magdeburg Median Kliniken GmbH & CoConcluído
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Klinik BavariaAinda não está recrutandoAfasia Adquirida
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Gabinete Berthier y MartínezH. Lundbeck A/SConcluído