Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Alternating Current Stimulation, Sham (No Treatment).
- Who it may be relevant to
- Registry conditions: Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Transcranial Alternating Current Stimulation
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 wit - Device Sham (No Treatment)
Wear the transcranial electrical stimulator without applying electric current
Primary outcome measures
- Incidence of Postoperative Anxiety Within 3 Days After Surgery [Time frame: From the day of surgery up to postoperative day 3]
Secondary outcome measures (9)
- Severity of postoperative anxiety [Time frame: 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 [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 pain intensity assessed by Numeric Rating Scale score [Time frame: 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 [Time frame: 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]
- 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]
- Time to ambulation [Time frame: Day of surgery, postoperative days 1, 2, 3]
- Length of hospital stay [Time frame: From the day when patient hospitalization to 3 weeks after surgery]
- Incidence of adverse events, complications, and 30-day all-cause mortality [Time frame: Up to 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Xuanwu Hospital — Beijing
Identifiers
NCT: NCT07713368 · linyanshen[2026]205-002