θTACS for Schizophrenia (SCZ) (θ-sch-dlPFC)
Efficacy and Safety of θ-transcranial Alternating Current Stimulation for Schizophrenia: A Randomized, Double-Blind, Sham-Controlled Trial
This is a double-blind, sham-controlled randomized study to test whether theta transcranial alternating current stimulation (theta tACS) at 4.5 Hz or 6 Hz, added to standard clinical care, improves symptoms of schizophrenia and is safe and well tolerated. Approximately 150 adults aged 18 to 60 years with schizophrenia will be randomly assigned equally to one of three groups: active 4.5 Hz tACS, active 6 Hz tACS, or sham tACS. Both participants and outcome assessors will be masked to group assignment.
All participants will continue their usual clinical treatment. They will receive one 40-minute tACS session per day over 10 working days (10 sessions total). Symptom assessments will take place at baseline, immediately after the stimulation period, Day 30, and Day 56. Magnetic resonance imaging (MRI) scans will be collected at baseline and post-stimulation. Adverse events will be monitored throughout the study.
The primary goal is to compare whether active theta tACS leads to a greater reduction in overall schizophrenia symptoms from baseline to Day 15 relative to sham tACS. Secondary assessments include symptom changes at other follow-up time points, changes in specific symptom domains, treatment completion rate, safety, and brain imaging changes.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This randomized, double-blind, parallel-group, sham-controlled trial aims to evaluate the efficacy, safety and tolerability of two theta-band tACS protocols (4.5 Hz and 6 Hz) as an add-on intervention for adults with schizophrenia. One hundred and fifty eligible participants will be allocated in a 1:1:1 ratio to 4.5 Hz active tACS, 6 Hz active tACS, or sham tACS. All participants maintain stable standard clinical care during the trial. The stimulation schedule consists of 40-minute daily sessions on 10 consecutive working days. Clinical symptom ratings are scheduled at baseline, post-intervention, Day 30 and Day 56. Structural and functional MRI data are acquired at baseline and post-intervention to explore brain correlates of treatment response. Adverse events are actively monitored at all study visits. The primary outcome is the change in total schizophrenia symptom severity from baseline to Day 15, comparing active stimulation arms versus sham. Secondary outcomes include longitudinal symptom trajectories, domain-specific symptom changes, intervention adherence, safety outcomes, and MRI-derived brain measures.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Li Zhang, doctor
- Numero di telefono: +8613856007916
- Email: cocozhangli@126.com
Backup dei contatti dello studio
- Nome: Gongjun Ji, professor
Luoghi di studio
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Anhui
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Hefei, Anhui, Cina, 230022
- the Afffliated Psychological Hospital of Anhui Medical University
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Contatto:
- Li Zhang, doctor
- Numero di telefono: +8655163616908
- Email: cocozhangli@sohu.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 18 to 60 years.
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Positive and Negative Syndrome Scale (PANSS) total score of at least 60 at screening.
- Initiation, dose adjustment, or switching of antipsychotic medication within the preceding 72 hours.
- The participant or legally authorized representative is able to understand the study procedures and voluntarily provide written informed consent, as applicable.
- Ability to cooperate with MRI scanning, TI treatment, clinical assessments, and follow-up visits during the study.
Exclusion Criteria
- History of a suicide attempt, or a score of 3 or higher on item 3 (suicidal ideation) of the 17-item Hamilton Depression Rating Scale at screening.
- A current DSM-5 diagnosis of another major psychiatric disorder, such as bipolar disorder, major depressive disorder with psychotic features, schizoaffective disorder, or substance/medication-induced psychotic disorder.
- A major neurological disorder, such as organic brain damage or severe traumatic brain injury.
- A contraindication to TI or MRI, including an implanted electronic device; MRI-incompatible intracranial or other metallic implants; wounds or active infection of the scalp at electrode contact sites; severe allergy to electrodes or conductive materials; severe claustrophobia; inability to lie supine; or another condition judged by the investigator to make TI or MRI unsuitable.
- Pregnancy or breastfeeding.
- Receipt of TI, another form of transcranial electrical stimulation, or electroconvulsive therapy within the preceding 6 months.
- Alcohol or another psychoactive substance use disorder within the preceding 6 months, or urine/blood toxicology at screening indicating recent use of illicit psychoactive substances.
- A history of seizures, a clear familial risk of epilepsy, or use of medication that substantially lowers the seizure threshold and cannot be adjusted.
- Severe or unstable physical illness, including uncontrolled cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, serious systemic infection, malignancy, or severe endocrine/metabolic abnormalities, that may increase study risk or interfere with study completion in the investigator's judgment.
- Severe aggression or impulsivity, agitation, delirium, impaired consciousness, or another acute condition that prevents safe cooperation with TI, MRI, or clinical assessments.
- Significant cognitive impairment, intellectual disability, language or hearing impairment, or another condition that prevents understanding of study requirements, completion of assessments, or provision of reliable information.
- Participation in another interventional clinical study within 3 months before screening, or current participation in another study that may affect evaluation of efficacy or safety in this study.
- Anticipated poor adherence, difficulty completing follow-up, or any other condition that, in the investigator's judgment, would compromise participant safety or rights, interfere with study completion, or affect interpretation of the study results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Active 4.5Hz θ tACS Stimulation
participants will receive active 4.5Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 4.5Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. |
The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 4.5 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial. |
|
Sperimentale: Active 6Hz θ tACS Stimulation
participants will receive active 6Hz tACS once daily for 10 work days. The central target electrode was placed over F3, with four surrounding return electrodes positioned at FP1, Fz, C3, and F7. Sinusoidal theta-band alternating current was delivered between the central target electrode and the four return electrodes; polarity reverses continuously during stimulation, so no fixed anode or cathode is present.Sinusoidal 6Hz theta-band tACS was delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasted 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. |
The montage uses one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Sinusoidal theta-band tACS at 6 Hz is delivered at a peak current of 2 mA. Each of the ten stimulation sessions lasts 40 minutes, with a 30-second ramp-up and a 30-second ramp-down period. Current polarity reverses continuously during stimulation, so no fixed anode or cathode is defined. Participants continue stable standard clinical care throughout the trial. |
|
Comparatore fittizio: tACS Stimulation
The sham tACS arm uses the identical electrode montage: one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7. Each session follows the same 40-minute timeline and identical 30-second ramp-up and 30-second ramp-down procedures as the active stimulation arms. Sinusoidal theta-band current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All other procedural aspects, including device setup, skin preparation, and participant instructions, are identical to the active arms to preserve masking. Participants continue stable standard clinical care throughout the study. |
Identical electrode montage (one central target electrode at F3 and four surrounding return electrodes at FP1, Fz, C3, and F7) and the same 40-minute session schedule with 30-second ramp-up and ramp-down periods as the active tACS arms. Sinusoidal current is delivered only during the ramp-up and ramp-down phases. No sustained alternating current is applied for the remainder of the session. All operational procedures, skin preparation, and device appearance are matched to the active arms to maintain masking. Participants continue stable standard clinical care throughout the trial. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 15
Lasso di tempo: Baseline (Day 0) and Day 15
|
The Positive and Negative Syndrome Scale (PANSS) is a clinician-rated instrument used to assess positive symptoms, negative symptoms, and general psychopathology in schizophrenia. The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. The primary outcome is the change in PANSS total score from baseline to Day 15, compared between the active and sham groups. Change is calculated as the Day 15 total score minus the baseline total score, with negative values indicating improvement. |
Baseline (Day 0) and Day 15
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in PANSS Total Score at Days 30 and 56
Lasso di tempo: Baseline (Day 0), Day 15, Day 30, and Day 56
|
The PANSS total score ranges from 30 to 210, with higher scores indicating greater schizophrenia symptom severity. Change at each visit will be calculated as the visit total score minus the baseline total score. Negative changes indicate improvement. Day 30 and Day 56 will be evaluated separately. |
Baseline (Day 0), Day 15, Day 30, and Day 56
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Change From Baseline in PANSS Positive Subscale Score
Lasso di tempo: Baseline (Day 0), Day 15, Day 30, and Day 56
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The PANSS positive subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe positive symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement. |
Baseline (Day 0), Day 15, Day 30, and Day 56
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Change From Baseline in PANSS Negative Subscale Score
Lasso di tempo: Baseline (Day 0), Day 15, Day 30, and Day 56
|
The PANSS negative subscale comprises 7 items, each scored from 1 to 7, yielding a total score from 7 to 49. Higher scores indicate more severe negative symptoms. Change at each visit will be calculated as the visit score minus the baseline score; a negative value indicates improvement. |
Baseline (Day 0), Day 15, Day 30, and Day 56
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Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Total Score
Lasso di tempo: Baseline (Day 0), Day 15, Day 30, and Day 56
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The AHRS assesses the severity of auditory hallucinations across seven dimensions. As specified in the protocol, the total score ranges from 0 to 41, with higher scores indicating more severe auditory hallucinations. Change at each visit will be calculated as the visit total score minus the baseline total score; a negative value indicates improvement. |
Baseline (Day 0), Day 15, Day 30, and Day 56
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Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score
Lasso di tempo: Baseline (Day 0), Day 15, Day 30, and Day 56
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The HAMD-17 is a 17-item clinician-rated measure of depressive symptom severity. Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. Changes from baseline to Days 7, 15, and 45 will be compared between the active TI and sham groups. Change is calculated as the total score at each follow-up visit minus the baseline total score, with negative values indicating improvement. |
Baseline (Day 0), Day 15, Day 30, and Day 56
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Changes From Baseline in low-frequency fluctuation (ALFF) of resting-state functional MRI (rs-fMRI) metrics
Lasso di tempo: Baseline (Day 0), Day 15, and Day 56
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Changes in resting-state brain functional measure, amplitude of low-frequency fluctuation (ALFF). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement . |
Baseline (Day 0), Day 15, and Day 56
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Changes From Baseline in regional homogeneity (ReHo) of resting-state functional MRI (rs-fMRI) metrics
Lasso di tempo: Baseline (Day 0), Day 15, and Day 56
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Changes in resting-state brain functional measure, regional homogeneity (ReHo). Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement . |
Baseline (Day 0), Day 15, and Day 56
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Changes From Baseline in functional connectivity of resting-state functional MRI (rs-fMRI) metrics
Lasso di tempo: Baseline (Day 0), Day 15, and Day 56
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Changes in resting-state brain functional measure, functional connectivity (FC) within predefined regions of interest. Comparisons will be made between active tACS arms and the sham arm, along with associations between imaging changes and symptom improvement . |
Baseline (Day 0), Day 15, and Day 56
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