Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
28 de março de 2022 atualizado por: Shanghai Mental Health Center
Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents
The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway.
A random controlled trial will be used to test the effect of θ-tACS treatment.
Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse.
Executive-control dysfunction is the main symptom for substance dependents.
Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway.
Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization.
But it has not been verified among MA or alcohol patients.
The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway.
A random controlled trial will be used to test the effect of θ-tACS treatment.
Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
210
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: Jiang Du
- Número de telefone: 021-64906315
- E-mail: dujiangdou@163.com
Locais de estudo
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Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai Mental Health Center
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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 a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
- Have used amphetamine or alcohol for at least one year (at least once a week)
- Normal vision and hearing, or within the normal range after correction
- Agree to cooperate in the follow-up evaluation
- No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity
Exclusion Criteria:
- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- Have used drugs promoting cognitive function in the last 6 months
- Have impaired intelligence (IQ<70)
- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Healthy control group
No intervention is conducted in the healthy control group.
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Experimental: Intervention group of amphetamine addiction
A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction.
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The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state.
Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value.
The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared.
The current value at this time was used as the stimulation current of the subjects.
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Comparador Falso: Control group of amphetamine addiction
A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction.
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The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.
|
|
Experimental: Intervention group of alcohol addiction
A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state.
Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value.
The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared.
The current value at this time was used as the stimulation current of the subjects.
|
|
Comparador Falso: Control group of alcohol addiction
A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The change of inhibitory control ability
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of theta(θ) phase synchronicity
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of theta-gamma phase amplitude coupling(θ-γ PAC)
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The change of working memory
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of working memory will be measured by the two-back task.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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DA metabolic rate
Prazo: baseline
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DA metabolism was measured by Positron Emission Computed Tomography
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baseline
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The change of decision-making ability
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of decision-making ability will be measured by the Balloon Analog Risk Task.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The The change of depression
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Depression will be measured by the Patient Health Questionnaire-9(PHQ-9).
The total score of PHQ-9 ranged from 0 to 27, in which higher scores mean a higher level of depression.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of anxiety
Prazo: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Anxiety will be measured by the questionnaire of Generalized Anxiety Disorder(GAD-7).
The total score of GAD-7 ranged from 0 to 21, in which higher scores mean a higher level of anxiety.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Antecipado)
1 de junho de 2022
Conclusão Primária (Antecipado)
1 de junho de 2025
Conclusão do estudo (Antecipado)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
5 de março de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de março de 2022
Primeira postagem (Real)
5 de abril de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de março de 2022
Última verificação
1 de janeiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- JDu-010
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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