Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures (ICD-10 72.01-72.2); Delirium - Postoperative
• Intervention / Treatment: Device: active tDCS; Device: sham tDCS

Detailed Description

1. Screening The trial staff will review orthopedic inpatient registration lists and elective surgery application forms to identify adults aged 65 years and older scheduled for surgical repair of clinically or radiologically diagnosed femoral neck, intertrochanteric, or subtrochanteric hip fractures. Potential participants will be screened for eligibility based on inclusion and exclusion criteria, which will be assessed through medical record reviews and face-to-face interviews.
2. Specific intervention The standard intervention consists of two sessions of tDCS and four sessions of fNIRS. The tDCS sessions will be administered on the day of surgery: the first session will be conducted preoperatively and the second session will take place postoperatively in the PACU. The fNIRS assessments will be performed as part of the monitoring protocol at four designated time points throughout the study.
3. Four fNIRS procedures will be conducted in relation to the tDCS interventions: (1) f1 (pre first tDCS) will be conducted before the first tDCS session; (2) f2 (post first tDCS, pre-surgery) will be conducted after the first tDCS session and before surgery; (3) f3 (post-surgery, before second tDCS) will be conducted after surgery and before the second tDCS session; (4) f4 (post second tDCS) will be conducted after the second tDCS session.

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lichao xue; Phone Number: +8613835187186; Email: 13835187186@163.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Xiaomin zhang; Phone Number: +8618435148730; Email: sxdyyky@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(1) aged ≥ 65 years; (2) scheduled for elective hip fracture, including femoral head fractures, femoral neck fractures, intertrochanteric or subtrochanteric fractures, femoral head replacement, total hip arthroplasty, or open or closed reduction; (3) platelet count > 80 × 10⁹/L; (4) ASA classification ≤ Grade III; (5) Mini-Mental State Examination (MMSE) scores ≥ 18 points (13); (6) willingness to participate and sign the informed consent form.

Exclusion Criteria:

(1) severe mental disorders,(e.g,depression or schizophrenia requiring medication treatment); (2) cranial or scalp injuries; (3) history of symptomatic cerebrovascular disease, including stroke, transient ischemic attack; (4) compound injuries, multiple fractures, periprosthetic fractures, and hip joint revisions; (5) drug or alcohol abuse; (6) severe visual or hearing impairments; (7) history of epilepsy or intracranial metal implants; (8) severe cardiovascular disease history and liver dysfunction, or kidney dysfunction; (9) coagulation abnormalities; (10) severe chronic obstructive pulmonary disease; (11) participation in other clinical studies within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active tDCS; The active-tDCS group will receive a 15-second ramp up phase at the start, 2 mA of tDCS for 20 minutes and a 15-second ramp down phase at the end.	Device: active tDCS; The active-tDCS group will receive a 15-second ramp up phase at the start, 2 mA of tDCS for 20 minutes and a 15-second ramp down phase at the end.
Sham Comparator: sham tDCS; The sham-tDCS group will only receive the 15-second ramp up phase at the beginning and the 15-second ramp down phase at the end of each session, without the continuous 2 mA current for 20 minutes	Device: sham tDCS; The sham-tDCS group will only receive the 15-second ramp up phase at the beginning and the 15-second ramp down phase at the end of each session, without the continuous 2 mA current for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	Delirium will be assessed during the first three postoperative days.The Confusion Assessment Method (CAM) assessment is based on the four key features of delirium: acute onset and fluctuating course, disorganized thinking, inattention, and altered levels of consciousness. Investigators will also consult the medical record or contact a family member, friend, or health care provider who knows the patient well to gather additional information regarding the patient's symptoms.	postoperative days 1, 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subtypes of postoperative delirium.	Delirium subtypes will be assessed using the Richmond Agitation Sedation Scale (RASS) . Hyperactive delirium is characterized by symptoms ranging from mild restlessness to persistent motor activity and irritability. Conversely, hypoactive delirium is characterized by one or more of the following features: reduced or absent movement, minimal verbal communication despite stimulation, and a lack of responsiveness. Mixed delirium is characterized by rapid fluctuations between the hyperactive and hypoactive states.	postoperative days 1, 2 and 3
pain score	Pain at rest and during movement will be assessed using the Numeric Rating Scale (NRS) , an 11-point scale where 0 denotes no pain and 10 represents the worst possible pain.	postoperative days 1, 2 and 3

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Hua Zheng, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Fractures, Bone; Femoral Fractures; Hip Injuries; Emergence Delirium; Delirium; Hip Fractures
• Other Study ID Numbers: YXLL-2024-191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Paper case report forms were written by hand

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes