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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Fuyang, Chiny
- Fuyang Mental Heath Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Beta2-band EEG power at the stimulation site
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Alpha-band EEG power at the stimulation site
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- HFJiang-006
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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