Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient (Taph)
25 de julho de 2016 atualizado por: AZOUVI, Centre d'Investigation Clinique et Technologique 805
Aphasia is a frequent symptom after a left hemisphere stroke.
It has serious impacts on social, family and professional lives.
Aphasic patients need to be rehabilitated.
To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate.
Several studies have investigated the link between the recovery of language and neural reorganization.
tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT.
About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients.
However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated.
That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
This is a multicenter, cross-over, randomized, controlled and double blind study. 24 patients will be included between November 2015 and November 2017.
During each session of speech and language treatment, aphasics will receive a weak 2 milli amperes (electric) current delivered by a tDCs device for 20 minutes. The stimulation will be either active or placebo. Each stage of the cross over will last three weeks. Patients will be administered the usual number of SLT sessions, no particular therapy being imposed. To evaluate the long-time effects of the therapy, three follow-up measures will be proposed.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
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.
Contato de estudo
- Nome: Philippe AZOUVI, MDPHD
- Número de telefone: 0033147107074
- E-mail: philippe.azouvi@aphp.fr
Estude backup de contato
- Nome: Nicolas ROCHE, MD
- Número de telefone: 0033147107900
- E-mail: roche.nicolas@rpc.aphp.fr
Locais de estudo
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Garches, França, 92380
- Recrutamento
- Hôpital Raymond Poincaré
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Contato:
- PHILIPPE AZOUVI, MDPHD
- Número de telefone: 0033147107074
- E-mail: philippe.azouvi@rpc.aphp.fr
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Contato:
- SANDRA POTTIER, CRA
- Número de telefone: 0033147104469
- E-mail: sandra.pottier@rpc.aphp.fr
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patient more than 18 years
- Aphasic Following a brain injury identified by MRI.
- Present a aphasia severity score> 1 on the Boston Diagnostic Aphasia Examination (BDAE) severity scale.
- No Post stroke delay is retained but the patient should be stable from a medical point of view.
- Master Of the French language in spoken and written
- Affiliated to a social security
- Patient Who signed the informed consent
Exclusion Criteria:
- Other previous neurological pathologies
- epileptic crisis during the previous 2 months
- Patient denies
- Presence of a cranial flap
- intracerebral metal hardware Presence
- Patient under guardianship
- Patient unable to understand the study
- Patient subject to an exclusion period for another search.
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 cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Aphasics Patients
Patients which have difficulties to speak.
Improvement of language for aphasics patients.
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Aphasics patients receive active stimulation during SLT
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Comparador Falso: Aphasics Patients control
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
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Aphasics patients receive active stimulation during SLT
Aphasics patients control receive sham stimulation during SLT
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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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change of number of names, without error and not repeated in the speech
Prazo: Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th
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The participant must answer a simple question "explain me your job or your study". Their production will be recorded and analyzed. For evaluate the stability of participant performances before the stimulation period three based line will be propose. The third base line corresponds to the start of the first stimulation period. After the three week of tdcs coupled with the SLT a new assessment will be realized. One week later begin the new stage of cross over. An assessment will be administered just before and just after the second stimulation period. Then, three follow-up assessments (one all two weeks) will be proposed during one and half month. |
Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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verbal fluency
Prazo: Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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the participant has two minutes to find the most animal names words beginning by letter p. Investigator collect the number of correct words and calculate the standard deviation according to published norms.
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Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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working memory
Prazo: baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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the participant repeats the numbers in the same order or inverted order.
Investigator collect the highest group of number repeated
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baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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visual exploration
Prazo: baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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a paper with a lot of drawing is presented to the participant.
The participant must delete all the bells as fast as possible.
Investigator collect the number of bell omissions
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baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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every day life scale
Prazo: Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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a questionnaire is proposed to the participant in order to better understanding how is the communication with their close or with unknown person in a conversation or phone
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Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week.
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likert scale
Prazo: at the end of the 9 th week, a likert 5 grade scale was proposed.
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likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist.
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at the end of the 9 th week, a likert 5 grade scale was proposed.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Philippe AZOUVI, MDPHD, Hôpital Raymond Poincaré
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
- Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. doi: 10.1002/14651858.CD000425.
- Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3.
- Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87. doi: 10.1044/jslhr.4101.172.
- Klippi A, Sellman J, Heikkinen P, Laine M. Current clinical practices in Aphasia Therapy in Finland: challenges in moving towards national best practice. Folia Phoniatr Logop. 2012;64(4):169-78. doi: 10.1159/000341106. Epub 2012 Oct 25.
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 novembro de 2015
Conclusão Primária (Antecipado)
1 de novembro de 2017
Conclusão do estudo (Antecipado)
1 de outubro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
29 de outubro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de novembro de 2015
Primeira postagem (Estimativa)
24 de novembro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de julho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de julho de 2016
Última verificação
1 de julho de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2014-A01773-44
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