rTMS for Working Memory Deficits in Schizophrenia
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Working Memory Deficits in Schizophrenia and Effects on Brain Structure
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation as a treatment for working memory deficits in individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess symptom severity as part of the clinical assessment. Cognition will be assessed using a validated battery and the N-back task.
This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while you are completing some basic tasks to assess brain function. We will also collect two blood samples (before and after rTMS treatment) to see if certain proteins change in response to treatment. Finally, an analysis of genetic material will be conducted to see if genes play a role in differences in how people respond to treatment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá
- Centre for Addiction and Mental Health
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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:
- Between 18 and 59 years of age
- Current diagnosis of Schizophrenia or Schizoaffective Disorder
- Able to provide written informed consent
- Fluency in the English Language
Exclusion Criteria:
- Have a history of substance abuse or dependence in the last 6 months
- Have a concomitant major and unstable medical or neurologic illness
- Have a history of seizures or have a first degree relative with a history of a seizure disorder
- Current pregnancy or a plan to become pregnant during the duration of the study
- Clinical instability: determined by treating physician
- Have received electroconvulsive therapy (ECT) within the last year
- Have a history of repetitive transcranial magnetic stimulation (rTMS)
- Are taking a benzodiazepine at a dose greater than Lorazepam 2mg or equivalent
- Are taking any non-benzodiazepine anticonvulsant
- Have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Active rTMS
Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 stimulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left then right) will be held constant for all 20 treatments. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS é um procedimento não invasivo que envolve o uso de campos magnéticos para estimular as células nervosas.
Outros nomes:
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Comparador Falso: Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Intervention: Device: Repetitive Transcranial Magnetic Stimulation |
rTMS é um procedimento não invasivo que envolve o uso de campos magnéticos para estimular as células nervosas.
Outros nomes:
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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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Performance on the N-back working memory task
Prazo: 4 weeks
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The primary outcome measure will be the performance on the N-back working memory task. Specifically, we will evaluate if rTMS results in a change in percent of correct responses in the N-back task. Note: the N-back is a continuous performance task that is commonly used to measure attention and working memory. |
4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Brain Imaging Changes
Prazo: 4 weeks
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For brain imaging we will test for group differences using: (1) cortical thickness (2) volumetric measures, (3) diffusion based measures.
Statistical tests measuring these differences will be conducted at baseline and following the final rTMS treatment session.
We will control for possible effects of neuroleptic medication on MRI measures by regressing mean dosage levels multiplied by number of years on medication, for each of five classes of medication (typical neuroleptics, atypical neuroleptics, antiparkinsonian anticholinergics, lithium, benzodiazepines)
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Aristotle Voineskos, MD, PHD, Centre for Addiction and Mental Health
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
Outros números de identificação do estudo
- 057/2013
Plano para dados de participantes individuais (IPD)
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Ensaios clínicos em Estimulação Magnética Transcraniana Repetitiva
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus MedicalConcluído