Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
15 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
102
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: wei Xiao
- Número de teléfono: +8613810971299
- Correo electrónico: kitten15@126.com
Ubicaciones de estudio
-
-
-
Beijing, Porcelana, 100053
- Xuanwu Hospital
-
Contacto:
- Wei Xiao, Doctor
- Número de teléfono: 8613810971299
- Correo electrónico: kitten15@126.com
-
Investigador principal:
- Wei Xiao, Doctor
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
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.
|
Wear the transcranial electrical stimulator without applying electric current
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Postoperative Anxiety Within 3 Days After Surgery
Periodo de tiempo: From the day of surgery up to postoperative day 3
|
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.
|
From the day of surgery up to postoperative day 3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Severity of postoperative anxiety
Periodo de tiempo: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
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.
|
1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
|
Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
Periodo de tiempo: In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
|
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.
|
In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3
|
|
Postoperative pain intensity assessed by Numeric Rating Scale score
Periodo de tiempo: 1 day before surgery, 6, 24, 48, and 72 hours after surgery
|
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.
|
1 day before surgery, 6, 24, 48, and 72 hours after surgery
|
|
Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
Periodo de tiempo: 1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
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.
|
1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
|
Sleep quality assessed by Pittsburgh Sleep Quality Index score
Periodo de tiempo: 1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
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.
|
1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery
|
|
Quality of recovery assessed by 15-item Quality of Recovery score
Periodo de tiempo: Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
|
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.
|
Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery
|
|
Time to ambulation
Periodo de tiempo: Day of surgery, postoperative days 1, 2, 3
|
Time to first ambulation after surgery will be recorded and compared between groups.
|
Day of surgery, postoperative days 1, 2, 3
|
|
Length of hospital stay
Periodo de tiempo: From the day when patient hospitalization to 3 weeks after surgery
|
Total length of hospital stay will be recorded and compared between groups.
|
From the day when patient hospitalization to 3 weeks after surgery
|
|
Incidence of adverse events, complications, and 30-day all-cause mortality
Periodo de tiempo: Up to 30 days after surgery
|
Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
|
Up to 30 days after surgery
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum substance P concentration
Periodo de tiempo: 2 days before surgery and 2 days after surgery
|
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.
|
2 days before surgery and 2 days after surgery
|
|
Changes in Electroencephalographic Oscillations
Periodo de tiempo: 2 days before surgery and 2 days after surgery
|
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.
|
2 days before surgery and 2 days after surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de julio de 2026
Publicado por primera vez (Actual)
20 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- linyanshen[2026]205-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The study protocol can be obtained by contacting the PI after publication.
Marco de tiempo para compartir IPD
1 year after publication
Criterios de acceso compartido de IPD
The study protocol can be obtained by contacting the PI after publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .