Inhibitory rTMS in Dystonic Wilson Patients (WILSTIM)
Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation
Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. The neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. Treatment is limited and only partially effective.
Low frequency (<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.
Visão geral do estudo
Status
Descrição detalhada
This study investigates the handwriting performance of an homogeneous cohort of patients with Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one single 20 minutes session. Handwriting performance will be measured immediately after this unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. Three days later, the patient will receive the other session (sham rTMS or active rTMS) and the same parameters will be evaluated.
This is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the session).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ile De France
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Paris, Ile De France, França, 75010
- Hospital Lariboisière
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Wilson disease with focal right hand dystonia
- No modification of medical treatment for 6 months
- No botulinum toxin administration within the past four months
- Right handed
- Focal right hand dystonia
- Cerebral Magnetic Resonance performed the last 6 months with no other lesion than met in Wilson disease
- Over 18
- Insurance policy holder
- Informed consent
Exclusion Criteria:
- Pregnant woman
- Guardianship procedure
- Seizure history
- Other cerebral lesions on cerebral MRI than met in Wilson Disease
- Unable to stay quiet for 30 minutes
- Handwriting impossible
- Contra-indications to repetitive Transcranial Magnetic Stimulation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Active rTMS
Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
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Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
to verify the absence of infraclinical seizures
Writer's cramp rating scale
handwriting in development and being evaluated by the NRC Wilson
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Comparador Falso: Sham rTMS
Placebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
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Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
to verify the absence of infraclinical seizures
Writer's cramp rating scale
handwriting in development and being evaluated by the NRC Wilson
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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immediate and significant improvement in writing
Prazo: up to 1 week
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Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex. quantitative test score of writing WCRS Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later. |
up to 1 week
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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significant improvement in writing
Prazo: up to 1 week
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improvement of other quantitative test scores of writing (VAS subjective discomfort writing, DPRE scales and parameters measured on touchpad) after a single session of 1 Hz rTMS inhibitory to the left CSS , compared to the scores achieved in the 24 hours before the session of rTMS. Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later. |
up to 1 week
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improvement of dystonia on the scale WDRS
Prazo: up to 1 week
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Assessing the improvement of dystonia on the scale WDRS after a single session of 1 Hz rTMS inhibitory to the left CSS, compared to the scores achieved in the 24 hours before the session of rTMS. Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later. |
up to 1 week
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correlation between the scores and the other parameters of disease severity
Prazo: up to 1 week
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Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.
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up to 1 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Nathalie KUBIS, MD, PhD, Physiology Department, Lariboisière Hospital
- Investigador principal: Jean-Marc TROCELLO, MD, Neurology, Lariboisière Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Doenças Metabólicas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças do Fígado
- Doenças Genéticas, Congênitas
- Doenças dos Gânglios da Base
- Doenças Neurodegenerativas
- Metabolismo, Erros Inatos
- Distúrbios Heredodegenerativos, Sistema Nervoso
- Doenças Cerebrais Metabólicas
- Doenças Cerebrais Metabólicas Inatas
- Metabolismo de metais, erros inatos
- Distúrbios do Movimento
- Degeneração Hepatolenticular
Outros números de identificação do estudo
- P121105
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Ensaios clínicos em Repetitive Transcranial Magnetic Stimulation (rTMS)
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus MedicalConcluído