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NCT Number: NCT06678529

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

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.

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Key information

About this study

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: postoperative days 1, 2 and 3

    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.

Secondary outcomes

  1. Subtypes of postoperative delirium.

    Time frame: postoperative days 1, 2 and 3

    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.

  2. pain score

    Time frame: postoperative days 1, 2 and 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

lichao xue

CONTACT

[email protected]

+8613835187186

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 7, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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