What is this study trying to find out about postoperative delirium in elderly patients?

This study is evaluating whether transcranial direct current stimulation (tDCS) can help reduce the risk of postoperative delirium in elderly patients after hip fracture surgery. Researchers aim to understand how brain stimulation affects delirium and recovery. The study is led by Huazhong University of Science and Technology and involves careful monitoring during surgery and recovery.

Who may be eligible for this postoperative delirium clinical trial?

Adults aged 65 or older who are scheduled for elective hip fracture surgery may be eligible. Participants should not have severe mental disorders, recent strokes, or cranial injuries, and must have adequate platelet counts and mental status scores. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this postoperative delirium clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should prepare for possible out-of-pocket costs related to travel or accommodations.

Actively Recruiting

Phase Not Applicable

Age: 65Years +

All Genders

ID06678529

Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

Led by Huazhong University of Science and Technology · Updated on 2025-04-06

160

Participants Needed

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

Who Can Participate

Age: 65Years +

All Genders

Eligibility Criteria

You may qualify if you...

Aged 65 years or older
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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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

Trial Site Locations

Total: 1 location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China, 030032

Actively Recruiting

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Research Team

lichao xue

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

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