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tACS for Working Memory in Schizophrenia

8 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recrutamento
        • The Second Xiangya Hospital of Central South University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Falso: sham group
sham stimulation
Dispositivo: 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
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Working Memory Accuracy
Prazo: 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
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in MCCB Performance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Central South University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

6 de julho de 2026

Conclusão Primária (Estimado)

31 de outubro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • LYG20260081

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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