- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01647269
A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome
A Randomised, Controlled, Crossover Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Severe Tourette Syndrome
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is aimed at adults who have severe Tourette syndrome and who have found that conventional treatments, such as drugs, do not control their symptoms sufficiently or cannot be tolerated.
The first two clinic visits will involve assessments. Participants will fill in a number of questionnaires and be examined by a psychiatrist and a neurologist. At the second visit, the patient will provide consent for participation and will undergo formal tests to find out if the participant is suitable and willing to undergo the research study and to record the type and severity of their Tourette syndrome symptoms.
The third visit will be an admission to hospital to have the deep brain stimulation (DBS) devices implanted. The admission to hospital should be around five days in duration.
At the first post operative follow-up visit, the patient will be placed into a "stimulator on" group or a "stimulator off" group. To try and make sure that these groups are the same to start with, each patient is put into a group by chance (randomly). This visit will take place around six weeks after surgery. In this trial, the participant will have an equal chance of being in the "on" or the "off" group first. This trial is also a "blinded" trial, neither the patient nor the researchers performing the assessments will know which group the patient is in.
At the next visit, 3 months later, the patient will have a further assessment. If their stimulators have been "on" for the first 3 months, they will be switched off. If they have been "off" they will be switched on.
At the next visit, 3 months later, the patient will be assessed again and then given the opportunity to carry on the trial with the stimulators switched on for long term follow up.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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London, Reino Unido
- UCL Institute of Neurology
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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:
- The participant must be adult with stable Tourette syndrome.
- The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
- The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
- The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
- The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
- The participant must be actively involved with and compliant with any psychosocial interventions.
- The patient must be compliant with treatment plans.
Exclusion Criteria:
- The tic disorder is attributable to any other condition.
- Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
- Psychosocial factors which might impede operative and post-operative care and research participation.
- Coagulation problems
- Other disease compromising life expectancy
- Patient likely to benefit from psychological intervention
- Patient unwilling to co-operate with post operative assessment and care
- Pregnancy.
- Participant under 20 years old.
Plano de estudo
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 |
|---|---|
|
Experimental: DBS Off first
|
Bilateral GPi Deep Brain Stimulation
|
|
Experimental: DBS On First
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Bilateral GPi Deep Brain Stimulation
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Yale Global Tic Severity Scale
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
The Change in Scores on the Yale Global Tic Severity Scale will be compared between defined periods with stimulation switched ON v stimulation switched OFF.
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change in Modified Rush Video Rating scale
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
|
Change in Yale Brown Obsessive Compulsive Scale
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
|
Change in Neuropsychiatric Inventory
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
|
Change in Tourette Quality of life scale
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
|
Change in MOVES scale
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
|
Change in Beck Depression Inventory
Prazo: Three months after stimulation switched ON v three months after stimulation switched OFF
|
Three months after stimulation switched ON v three months after stimulation switched OFF
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Foltynie, MBBS PhD, UCL Institute of Neurology
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Processos Patológicos
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doença
- Doenças Genéticas, Congênitas
- Doenças dos Gânglios da Base
- Distúrbios do Movimento
- Doenças Neurodegenerativas
- Distúrbios Heredodegenerativos, Sistema Nervoso
- Distúrbios do Neurodesenvolvimento
- Transtornos de Tique
- Síndrome
- Síndrome de Tourette
Outros números de identificação do estudo
- UCL 11/0226
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 .