Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
15 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
102
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: wei Xiao
- Numero di telefono: +8613810971299
- Email: kitten15@126.com
Luoghi di studio
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Beijing, Cina, 100053
- Xuanwu Hospital
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Contatto:
- Wei Xiao, Doctor
- Numero di telefono: 8613810971299
- Email: kitten15@126.com
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Investigatore principale:
- Wei Xiao, Doctor
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of Postoperative Anxiety Within 3 Days After Surgery
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Severity of postoperative anxiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Serum substance P concentration
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
31 dicembre 2028
Completamento dello studio (Stimato)
31 marzo 2029
Date di iscrizione allo studio
Primo inviato
13 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- linyanshen[2026]205-002
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The study protocol can be obtained by contacting the PI after publication.
Periodo di condivisione IPD
1 year after publication
Criteri di accesso alla condivisione IPD
The study protocol can be obtained by contacting the PI after publication.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .