Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography
Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography in Patients With Auditory Hallucinations and Healthy Controls
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Fuyang, China
- Fuyang Mental Heath Center
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18 to 65 years;
- Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Adequate verbal communication skills;
- At least one auditory hallucination episode within the past week;
- Willing to participate in the study and able to complete all trial procedures.
Exclusion Criteria:
- History of neurological disorders, severe physical illness, traumatic brain injury, or craniotomy;
- History of epileptic seizures or other neuropsychiatric disorders;
- At risk for suicide, self-injury, or impulsive behavior.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: 0.4mA-10Hz HD-tACS
For 0.4mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 0.4mA-20Hz HD-tACS
For 0.4mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 20 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 0.4mA-40Hz HD-tACS
For 0.4mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 20 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 0.4mA-140Hz HD-tACS
For 0.4mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 1mA-10Hz HD-tACS
For 1mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 1mA-20Hz HD-tACS
For 1mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 1mA-40Hz HD-tACS
For 1mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 1mA-140Hz HD-tACS
For 1mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 2mA-10Hz HD-tACS
For 2mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 2mA-20Hz HD-tACS
For 2mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 2mA-40Hz HD-tACS
For 2mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: 2mA-140Hz HD-tACS
For 2mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
Experimental: sham HD-tACS
For sham HD-tACS, we will stimulate the personalized left or right temporal lobe channel using sham HD-tACS pattern.
|
The sham intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
To mimic the sensory experience of active stimulation, the sham condition includes a 10-second ramp-up and a 5-second ramp-down period at 0.4 mA and 140 Hz, with no current delivered during the intervening 90-second period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Beta2-band EEG power at the stimulation site
Prazo: 180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in beta2 band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Alpha-band EEG power at the stimulation site
Prazo: 180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in alpha band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Delta-band EEG power at the stimulation site
Prazo: 180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in delta band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Theta-band EEG power at the stimulation site
Prazo: 180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in theta band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Gamma-band EEG power at the stimulation site
Prazo: 180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in gamma band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Beta2-band functional connectivity measured by EEG wPLI
Prazo: 180-second recording after each 90-second stimulation
|
Beta2-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Alpha-band functional connectivity measured by EEG wPLI
Prazo: 180-second recording after each 90-second stimulation
|
Alpha-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Delta-band functional connectivity measured by EEG wPLI
Prazo: 180-second recording after each 90-second stimulation
|
Delta-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Theta-band functional connectivity measured by EEG wPLI
Prazo: 180-second recording after each 90-second stimulation
|
Theta-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Gamma-band functional connectivity measured by EEG wPLI
Prazo: 180-second recording after each 90-second stimulation
|
Gamma-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
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Outros números de identificação do estudo
Outros números de identificação do estudo
- HFJiang-006
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Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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