Actively Recruiting
Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients
Led by Huazhong University of Science and Technology · Updated on 2025-04-06
160
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery. This single-center, double-blind, randomized controlled trial will enroll participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 minutes simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.
CONDITIONS
Official Title
Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 years or older
- Scheduled for elective hip fracture surgery, including femoral head, neck, intertrochanteric or subtrochanteric fractures, femoral head replacement, total hip arthroplasty, or open/closed reduction
- Platelet count greater than 80 x 10⁹/L
- ASA classification Grade III or lower
- Mini-Mental State Examination (MMSE) score of 18 points or higher
- Willingness to participate and provide informed consent
You will not qualify if you...
- Severe mental disorders requiring medication treatment, such as depression or schizophrenia
- Cranial or scalp injuries
- History of symptomatic cerebrovascular disease, including stroke or transient ischemic attack
- Compound injuries, multiple fractures, periprosthetic fractures, or hip joint revisions
- Drug or alcohol abuse
- Severe visual or hearing impairments
- History of epilepsy or presence of intracranial metal implants
- Severe cardiovascular disease, liver dysfunction, or kidney dysfunction
- Coagulation abnormalities
- Severe chronic obstructive pulmonary disease
- Participation in other clinical studies within the past 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
Research Team
L
lichao xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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