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

NCT06678529 | Recruiting

• 1 other identifier: YXLL-2024-191
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Delirium - Postoperative; Hip Fractures (ICD-10 72.01-72.2)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subtypes of postoperative delirium.

  postoperative days 1, 2 and 3

• pain score

  postoperative days 1, 2 and 3

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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

sham tDCS

SHAM COMPARATOR

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

Interventions

active tDCS DEVICE

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.

active tDCS

sham tDCS DEVICE

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

sham tDCS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

Related Publications (1)

• Xue LC, Ji HJ, Fan SS, Niu Q, Zhang JY, Fang AL, Wang PZ, Tian SY, Zheng H. Effect of transcranial direct current stimulation on postoperative delirium in elderly patients undergoing hip fracture surgery: study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 May 15;12:1558376. doi: 10.3389/fmed.2025.1558376. eCollection 2025.

  PMID: 40443512 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Hip Fractures

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Hua Zheng

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lichao xue

CONTACT

+8613835187186; 13835187186@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will remain blinded to their group assignment. Surgeons, anesthesiologists, and ward and operating room nurses will also be blinded to the group allocations and intervention protocols. Additionally, personnel involved in outcome assessment, follow-up, data collection, and data processing will remain blinded to both the intervention protocols and group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Anesthesiology Department

Model Details: The tDCS procedure is administered using a transcranial direct current stimulator, with two electrodes placed in physiological saline soaked sponges. The electrodes are secured with a stretchable cap, positioning the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the right supraorbital area. 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. 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 .

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 7, 2024
• Study Start: November 1, 2024
• Primary Completion: November 20, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)