- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07798804
Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography
2026. augusztus 29. frissítette: Haifeng Jiang, Shanghai Mental Health Center
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
This study aims to investigate the after-effects of high-definition transcranial alternating current stimulation (HD-tACS) with varying parameters on resting-state brain activity in patients with schizophrenia experiencing auditory hallucinations.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
36
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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-
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Fuyang, Kína
- Fuyang Mental Heath Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
|
Kísérleti: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Beta2-band EEG power at the stimulation site
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Alpha-band EEG power at the stimulation site
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2025. december 5.
Elsődleges befejezés (Tényleges)
2026. február 11.
A tanulmány befejezése (Tényleges)
2026. február 15.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 1.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 29.
Első közzététel (Tényleges)
2026. szeptember 1.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 1.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 29.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- HFJiang-006
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
IPD terv leírása
Individual participant data will not be made publicly available because of privacy and confidentiality considerations related to the collection of electrophysiological data from human participants.
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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
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Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .