Studying Transcranial Direct Current Stimulation to Prevent Delirium After Hip Fracture Surgery in People 65 and Older
Led by Huazhong University of Science and Technology · Updated on 2025-04-06
160
Participants Needed
1
Research Sites
53 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether transcranial direct current stimulation tDCS can reduce the occurrence of postoperative delirium POD in elderly patients who undergo hip fracture surgery. This randomized controlled trial will include adults aged 65 years and older scheduled for elective hip surgeries such as femoral head fractures, femoral neck fractures, and hip replacements. The study aims to understand how tDCS impacts brain function and delirium after surgery.
Participants will be randomly assigned to either an active tDCS group or a sham tDCS group. The active group will receive two 20-minute tDCS sessions with a 2 mA current, one before surgery and one after surgery, with electrodes placed on specific areas of the head. The sham group will undergo similar sessions but without the actual stimulation current. Brain activity will be monitored using functional near-infrared spectroscopy fNIRS at four times before and after the tDCS sessions.
During the study, participants will be assessed for the presence and severity of postoperative delirium using the 3-Minute Diagnostic Interview for Confusion Assessment Method 3D-CAM on postoperative days 1, 2, and 3. Researchers will also evaluate pain levels, anxiety, depression, cognitive function, and sleep quality. The total involvement includes screening, two tDCS sessions, four brain monitoring sessions, and outcome assessments, with careful monitoring throughout the surgical and recovery periods.
CONDITIONS
Brief Title
Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients
Research Team
L
lichao xue
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Scheduled for elective hip fracture surgery including femoral head fractures, femoral neck fractures, intertrochanteric or subtrochanteric fractures, femoral head replacement, total hip arthroplasty, or open or closed reduction
Platelet count greater than 80 x 10⁹/L
ASA classification of Grade III or lower
Mini-Mental State Examination (MMSE) score of 18 points or higher
Willingness to participate and able to sign informed consent form
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 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 day (day of surgery)
Participants receive two sessions of transcranial direct current stimulation (tDCS): one preoperatively on the day of surgery and one postoperatively in the post-anesthesia care unit. Additionally, four functional near-infrared spectroscopy (fNIRS) assessments are performed at specific time points around the surgery and tDCS sessions.
1 surgery day with multiple assessments and tDCS sessions
Post-operative Follow-up
Duration - 3 days
Participants are monitored for postoperative delirium and other outcomes such as pain, anxiety, and cognitive function during the first three days after surgery.
Daily visits on postoperative days 1, 2, and 3
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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Published Research Related To This Trial
Effect of transcranial direct current stimulation on postoperative delirium in elderly patients undergoing hip fracture surgery: study protocol for a randomized controlled trial.