Xuanwu Hospital
Beijing, 100053, China
Not Yet Recruiting
NCT Number: NCT07713368
Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Transcranial Alternating Current Stimulation
DeviceThis 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.
Sham (No Treatment)
DeviceWear the transcranial electrical stimulator without applying electric current
Primary outcomes
-
Incidence of Postoperative Anxiety Within 3 Days After Surgery
Time frame: 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.
Secondary outcomes
-
Severity of postoperative anxiety
Time frame: 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.
-
Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score
Time frame: 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.
-
Postoperative pain intensity assessed by Numeric Rating Scale score
Time frame: 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.
-
Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score
Time frame: 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.
-
Sleep quality assessed by Pittsburgh Sleep Quality Index score
Time frame: 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.
-
Quality of recovery assessed by 15-item Quality of Recovery score
Time frame: 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.
-
Time to ambulation
Time frame: Day of surgery, postoperative days 1, 2, 3
Time to first ambulation after surgery will be recorded and compared between groups.
-
Length of hospital stay
Time frame: From the day when patient hospitalization to 3 weeks after surgery
Total length of hospital stay will be recorded and compared between groups.
-
Incidence of adverse events, complications, and 30-day all-cause mortality
Time frame: Up to 30 days after surgery
Incidence of adverse events, complications, and 30-day all-cause mortality will be monitored and compared between groups.
Other outcomes
-
Serum substance P concentration
Time frame: 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.
-
Changes in Electroencephalographic Oscillations
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Xuanwu Hospital, Beijing
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Jul 20, 2026
- Registry last updated
- Jul 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.