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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 6, 2025 (before its estimated November 20, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Nov 20, 2024 to Nov 20, 2025
    • Start date changed from estimate of Nov 15, 2024 to Nov 1, 2024
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 1,011 words
    • Site details revised
    • Study title expanded, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06678529
Lead Sponsor Huazhong University of Science and Technology
Conditions
(from sponsor)
Delirium - Postoperative, Hip Fractures (ICD-10 72.01-72.2)
Related terms Emergence Delirium, Hip Fractures
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov