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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Contact Information
Primary
lichao xue
13835187186@163.com
+8613835187186
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 160
Treatments
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.
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
Related Therapeutic Areas
Sponsors
Leads: Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov