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- Ensaio Clínico NCT03287037
The Effects of tDCS on Depressive Symptoms,Neurocognitive Function and HRV in Unipolar Depression and Bipolar Depression
To Investigate the Effect of Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms, Neurocognitive Function and Heart Rate Variability in Unipolar Depression and Bipolar Depression
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background
Transcranial direct current stimulation encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes . Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. The technique was established in the 1950s and 1960s primarily in animals. In these early studies it was shown that subthreshold DC stimulation increases spontaneous neuronal activity if the anode is placed above or within the cortex, while exposure to cathodal polarity results in reduced activity. This is caused by a subthreshold membrane depolarization by anodal and a hyperpolarization by cathodal stimulation. It was demonstrated in humans that the after-effects of tDCS depend on modifications of NMDA receptor-efficacy. The after-effects of tDCS are blocked by the NMDA receptor antagonist dextromethorphan, and prolonged by the partial NMDA receptor-agonist D-cycloserine. This tDCS polarity-dependent alteration of NMDA receptor function seems to be initiated by the respective membrane potential shift and probably by the accompanying cortical activity modification,because it is prevented by the sodium channel blocker carbamazepine. Intraneuronal calcium concentration also contributes, because calcium channel antagonists eliminate the excitability-enhancing after-effects of anodal tDCS. Recently, tDCS has been reported to be a novel, non-invasive and safe therapeutic tool to treat neuropsychiatric disorders including depression. This therapeutic tool has been reported to show promising effect in treating unipolar and bipolar depression. However, the sample sizes have been small. Further work is needed to see if these early promising studies replicate. Much evidence has indicated that patients with depression show hypoactivity over left dorsolateral prefrontal cortex (DLPFC) and hyperactivity over right DLPFC. We therefore hypothesize that tDCS over DLPFC with anode placed at left DLPFC and cathode placed at right DLPFC would reduce depressive symptoms in patients with unipolar depression and bipolar depression.
The study aimed to investigate whether tDCS over DLPFC could modify depressive symptoms, neurocognitive function and heart rate variability of unipolar and bipolar depression.
Study design: open-label study.
Participants: 60 patients with unipolar depression and 60 with bipolar depression.
Others: see Arms and Interventions, Eligibility Criteria or Outcome Measures.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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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:
Patients who met DSM-IV-TR criteria for major depressive disorder and bipolar depression and had moderate to severe depression severity (HAM-D score more than 17) were included in the study.
Exclusion Criteria:
- pregnancy or breastfeeding.
- having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence.
- having contraindications for transcranial electrical/magnetic stimulation.
- having intracranial metal foreign bodies.
- having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: tDCS over DLPFC
Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www.
neuroconn.de/dc-stimulator_plus_en/)
was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2).
The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4.
Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays.
The twice daily sessions were separated by at least 3 hours.
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We applied tDCS over dorsolateral prefrontal cortex (DLPFC) for these depressed patients.
Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www.
neuroconn.de/dc-stimulator_plus_en/)
was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2).
The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4.
Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays.
The twice daily sessions were separated by at least 3 hours.
All patients were maintained on their treatment throughout the study period.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from baseline score of Hamilton Depression Rating Scale (HAM-D) at the timepoint immediately after tDCS, at one week and one month after tDCS
Prazo: One month
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Depression severity
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One month
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from baseline score of Young Mania Rating Scale (YMRS) at the timepoint immediately after tDCS, at one week and one month after tDCS
Prazo: One month
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Hypomania/mania severity
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One month
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Changes from baseline score of Hamilton Anxiety Rating Scale (HAM-A) at the timepoint immediately after tDCS, at one week and one month after tDCS
Prazo: One month
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Anxiety severity.
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One month
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Changes from basline heart rate variability (HRV) at the timepoint immediately after tDCS, at one week and one month after tDCS
Prazo: One month
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Index of autonomic functioning.
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One month
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Changes from baseline results of continuous performance test (CPT) at the timepoint immediately after tDCS, at one week and one month after tDCS
Prazo: One month
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Performance of prefrontal-mediated task.
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One month
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2-103-03-002-1
Plano para dados de participantes individuais (IPD)
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