Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography
29 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
36
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Fuyang, Cina
- Fuyang Mental Heath Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Beta2-band EEG power at the stimulation site
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Alpha-band EEG power at the stimulation site
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
5 dicembre 2025
Completamento primario (Effettivo)
11 febbraio 2026
Completamento dello studio (Effettivo)
15 febbraio 2026
Date di iscrizione allo studio
Primo inviato
1 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 agosto 2026
Primo Inserito (Effettivo)
1 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HFJiang-006
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .