Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
15 de julho de 2026 atualizado por: Xuanwu Hospital, Beijing
The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery.
The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation.
This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
102
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
- Nome: wei Xiao
- Número de telefone: +8613810971299
- E-mail: kitten15@126.com
Locais de estudo
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Beijing, China, 100053
- Xuanwu Hospital
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Contato:
- Wei Xiao, Doctor
- Número de telefone: 8613810971299
- E-mail: kitten15@126.com
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Investigador principal:
- Wei Xiao, Doctor
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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
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age 18 to 65 years old
- Scheduled for elective intraspinal tumor resection under general anesthesia
- American Society of Anesthesiologists physical status I-III
- Able to understand and complete the Hospital Anxiety and Depression Scale and other study-related questionnaires
- Voluntarily sign the informed consent form
- Right handed
Exclusion Criteria:
- Preoperative HADS-A score ≥ 8
- History of psychiatric disorders (e.g., depression, psychosis) or use of psychotropic medications within the past 3 months
- History of neurological diseases (e.g., epilepsy, stroke, dementia) or severe head trauma
- Contraindications to transcranial alternating current stimulation, including metallic implants in the head, skull defects, or a history of seizures
- Severe visual or auditory impairment that affects communication
- severe cardiovascular and cerebral vascular diseases
- Participation in other clinical trials within the past 30 days
- A Mini-Mental State Examination (MMSE) score < 15
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Active Transcranial Alternating Current Stimulation Group
Participants receive active transcranial alternating current stimulation (tACS) at 10 Hz, 2 mA, applied bilaterally over the prefrontal cortex (F3/F4) for 20 minutes immediately after anesthesia induction during intraspinal tumor resection.
All participants receive standard anesthesia and surgical care per institutional protocols.
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This study uses intraoperative transcranial alternating current stimulation (tACS) delivered via a non-invasive, portable electrical stimulation device.
The intervention consists of 10 Hz alternating current at 2 mA intensity, applied bilaterally over the prefrontal cortex (F3/F4 electrode positions) for 20 minutes immediately following anesthesia induction during elective intraspinal tumor resection.
The device is calibrated to deliver a consistent, low-level current that does not interfere with standard anesthesia or surgical procedures.
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Comparador Falso: Sham Transcranial Alternating Current Stimulation Group
Participants receive sham transcranial electrical stimulation without electric current during the perioperative period.
All participants receive standard anesthesia and surgical care per institutional protocols, identical to the tACS group except for the study-specific stimulation intervention.
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Wear the transcranial electrical stimulator without applying electric current
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of Postoperative Anxiety Within 3 Days After Surgery
Prazo: From the day of surgery up to postoperative day 3
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The primary outcome is the incidence of postoperative anxiety, defined as a Hospital Anxiety and Depression Scale-Anxiety score ≥ 8 at any time point on the day of surgery or postoperative days 1, 2, or 3. Participants will be assessed by trained evaluators blinded to group allocation.
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From the day of surgery up to postoperative day 3
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Severity of postoperative anxiety
Prazo: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Anxiety severity will be evaluated using the Hospital Anxiety and Depression Scale-Anxiety score.
Assessments will be performed at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
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1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
Prazo: In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
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Postoperative delirium will be evaluated using the 3-minute Diagnostic Confusion Assessment Method score.
Assessments will be performed in the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3.
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In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
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Postoperative pain intensity assessed by Numeric Rating Scale score
Prazo: 1 day before surgery, 6, 24, 48, and 72 hours after surgery
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Postoperative pain intensity will be evaluated using the Numeric Rating Scale score at 1 day before surgery and at 6, 24, 48, and 72 hours after surgery.
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1 day before surgery, 6, 24, 48, and 72 hours after surgery
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Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
Prazo: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Frailty will be evaluated using the Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score at 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery.
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1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Sleep quality assessed by Pittsburgh Sleep Quality Index score
Prazo: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index score at 1 day before surgery, the day of surgery, postoperative days 1, 2, 3, and 3 months after surgery.
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1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
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Quality of recovery assessed by 15-item Quality of Recovery score
Prazo: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
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Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery score on the day of surgery, postoperative days 1, 2, 3, and 1 month after surgery.
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Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
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Time to ambulation
Prazo: Day of surgery, postoperative days 1, 2, 3
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Time to first ambulation after surgery will be recorded and compared between groups.
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Day of surgery, postoperative days 1, 2, 3
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Length of hospital stay
Prazo: From the day when patient hospitalization to 3 weeks after surgery
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Total length of hospital stay will be recorded and compared between groups.
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From the day when patient hospitalization to 3 weeks after surgery
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Incidence of adverse events, complications, and 30-day all-cause mortality
Prazo: Up to 30 days after surgery
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Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
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Up to 30 days after surgery
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Serum substance P concentration
Prazo: 2 days before surgery and 2 days after surgery
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Serum substance P levels will be measured by enzyme-linked immunosorbent assay (ELISA) at baseline (2 days before surgery), and at 2 days after surgery.
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2 days before surgery and 2 days after surgery
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Changes in Electroencephalographic Oscillations
Prazo: 2 days before surgery and 2 days after surgery
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Resting-state electroencephalography will be recorded at baseline (2 days before surgery), and at 2 days after surgery.
Changes in power spectral density (delta, theta, alpha, beta bands) and functional connectivity will be analyzed.
The association between these changes and postoperative anxiety outcomes will be explored.
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2 days before surgery and 2 days after surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
1 de julho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de março de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de julho de 2026
Primeira postagem (Real)
20 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 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
- linyanshen[2026]205-002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The study protocol can be obtained by contacting the PI after publication.
Prazo de Compartilhamento de IPD
1 year after publication
Critérios de acesso de compartilhamento IPD
The study protocol can be obtained by contacting the PI after publication.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
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
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