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tACS for Working Memory in Schizophrenia

8. Juli 2026 aktualisiert von: Renrong Wu, Central South University

Efficacy and Mechanisms of Transcranial Alternating Current Stimulation in Improving Working Memory in Patients With Schizophrenia

This study is a randomized, single-blind, sham-controlled crossover trial enrolling 30 schizophrenia patients, each receiving one active and one sham tACS session (7-day washout), targeting P3/P4 at individual alpha frequency (2mA, 30min) during a working memory task, with accuracy and reaction time as primary outcomes, alongside EEG and neurophysiological measures, to test the efficacy and mechanisms of individualized alpha-tACS on working memory.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a randomized, single-blind, sham-controlled, crossover exploratory trial that plans to enroll 30 inpatients with schizophrenia, randomized 1:1 into two groups, with all participants receiving one active and one sham tACS session in a crossover manner separated by a 7-day washout. Stimulation targets the parietal P3/P4 sites at individual alpha frequency, with an intensity of 2 mA and a duration of 30 minutes per session, delivered concurrently with a working memory task (SIRP). Primary outcomes are SIRP accuracy and reaction time, with concurrent task-state EEG recording, along with assessments of clinical symptoms, cognitive function, and neurophysiological markers including ASSR, MMN, and P300. The study aims to explore the efficacy and underlying neural mechanisms of individualized alpha-tACS in improving working memory in schizophrenia.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Rekrutierung
        • The Second Xiangya Hospital of Central South University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Aged 18-50 years, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
  • Spatial span T-score <40 on the MATRICS Consensus Cognitive Battery (MCCB).
  • Taking 1-2 antipsychotic medications, with stable dosage for at least 1 week prior to enrollment. No use of mood stabilizers, antidepressants, or excessive benzodiazepines (lorazepam equivalent >2 mg/day). The type and dosage of antipsychotic medications remain unchanged during the treatment period.
  • Impaired functioning in daily activities.
  • Willing to participate in this study and provide written informed consent.

Exclusion Criteria:

  • Previously diagnosed with or comorbid any other DSM-5 mental disorder besides schizophrenia.
  • Presence of significant mood symptoms or substance use disorder (other than caffeine and/or tobacco).
  • Presence of any contraindication to transcranial alternating current stimulation (tACS).
  • Received other forms of electrical or magnetic stimulation therapy within 1 month prior to enrollment.
  • History or current presence of any major physical illness, neurological disorder, or traumatic brain injury that may affect brain structure or function.
  • Pregnant or breastfeeding women, or women planning to become pregnant during the study period.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Schein-Komparator: sham group
sham stimulation
Gerät: sham stimulation
Sham stimulation provides only a 15-second ramp-up and ramp-down current at the beginning and end of each session to mimic the initial tingling or itching sensation on the scalp produced by real stimulation, but delivers no effective stimulation current during the main phase of the task period.
Experimental: active group
transcranial alternating current stimulation
Gerät: transcranial alternating current stimulation
For montage 1, active electrode at P3 (10-10 system), return electrodes at P1, P5, PO3, CP3. For montage 2, active electrode at P4, return electrodes at P2, P6, PO4, CP4. Conductive paste ensures impedance <10 kΩ. Individual alpha frequency is used, calculated before each session from mean EEG at P3/P4 during SIRP task. Stimulation intensity is 2 mA (peak-to-zero) via electric field modeling. Stimulation is delivered during SIRP task, 30 min total per session (including 15s ramp-up/down), with continuous sine wave output.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Working Memory Accuracy
Zeitfenster: Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.
Assessment of task accuracy on the Sternberg Item Recognition Paradigm (SIRP). Participants are required to judge whether a probe stimulus belongs to a previously memorized set, with memory set sizes of 1 and 5. The outcome is measured as the percentage of correct responses (0-100%) across all trials, with higher scores indicating better working memory performance.
Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.
Working Memory Reaction Time
Zeitfenster: Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.
Assessment of response speed on the Sternberg Item Recognition Paradigm (SIRP). Participants are required to judge whether a probe stimulus belongs to a previously memorized set, with memory set sizes of 1 and 5. The outcome is measured as the mean response latency for correct responses only, calculated from stimulus onset to the participant's button press, with shorter times indicating faster processing speed.
Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in MCCB Performance
Zeitfenster: Baseline, on the day after each of the two interventions
Assessment of cognitive function using the MATRICS Consensus Cognitive Battery (MCCB), a standardized cognitive assessment tool designed for schizophrenia and other neuropsychiatric conditions. The MCCB evaluates 9 cognitive domains: attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning and problem solving, social cognition, executive function, and fine motor skills. The overall cognitive composite score ranges from 20 to 100 (T-score), with higher scores indicating better cognitive performance.
Baseline, on the day after each of the two interventions
Changes in Positive and Negative Symptom Scale (PANSS) Scores
Zeitfenster: Before and one week after each of the two interventions.
Scores range from 30 to 210, with higher scores indicating more severe positive and negative symptoms.
Before and one week after each of the two interventions.
Changes in Scale for the Assessment of Negative Symptoms (SANS) Scores
Zeitfenster: Before and one week after each of the two interventions.
Scores range from 0 to 120; higher scores indicate more severe negative symptoms.
Before and one week after each of the two interventions.
Changes in Calgary Depression Scale for Schizophrenia (CDSS) Scores
Zeitfenster: Before and one week after each of the two interventions.
Scores range from 0 to 27; higher scores indicate more severe affective symptoms.
Before and one week after each of the two interventions.
Changes in Brain Function
Zeitfenster: Baseline, on the day after each of the two interventions.
Functional magnetic resonance imaging (fMRI), based on blood oxygen level-dependent (BOLD) contrast, can detect changes in blood oxygenation and analyze changes in brain function after intervention.
Baseline, on the day after each of the two interventions.
Changes in Neuroelectrophysiological Signals
Zeitfenster: Baseline, 30 minutes after each of the two interventions.
Changes in neuroelectrophysiological signals are collected through task-based electroencephalography (EEG).
Baseline, 30 minutes after each of the two interventions.
Changes in 40Hz Auditory Steady-State Response (40Hz-ASSR)
Zeitfenster: Baseline, 30 minutes after each of the two interventions.
The 40Hz auditory steady-state response recorded by EEG, including evoked power and inter-trial phase coherence, will be measured. The unit of measurement for evoked power is μV², and for coherence is unitless.
Baseline, 30 minutes after each of the two interventions.
Changes in Mismatch Negativity (MMN)
Zeitfenster: Baseline, 30 minutes after each of the two interventions.
Mismatch negativity amplitude recorded by EEG using an oddball paradigm will be measured. The unit of measurement is microvolts (μV).
Baseline, 30 minutes after each of the two interventions.
Changes in P300 Event-Related Potential
Zeitfenster: Baseline, 30 minutes after each of the two interventions.
P300 amplitude recorded by EEG using an oddball paradigm will be measured. The unit of measurement is microvolts (μV).
Baseline, 30 minutes after each of the two interventions.
Hallucination and Delusion Visual Analog Scale (HD-VAS) Score
Zeitfenster: Within 15 minutes after completion of Session 1; within 15 minutes after completion of Session 2.
Assessment of acute post-intervention changes in hallucination and delusion severity using a patient-rated visual analog scale (VAS). The scale consists of a 0-100 mm horizontal line, on which participants mark their current symptom severity. The distance (in millimeters) from the left anchor ("no symptoms") to the participant's mark is measured with a ruler. This scale serves as a supplementary measure to the PANSS to capture immediate symptom changes following each intervention. Scores range from 0 to 100 mm, with higher scores indicating more severe hallucinations and delusions.
Within 15 minutes after completion of Session 1; within 15 minutes after completion of Session 2.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Central South University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

6. Juli 2026

Primärer Abschluss (Geschätzt)

31. Oktober 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LYG20260081

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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