NCT06678529 Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients
| NCT ID | NCT06678529 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Delirium - Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-11-01 with a primary completion date of 2025-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hua Zheng
PRINCIPAL INVESTIGATOR
Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06678529 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Delirium - Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678529 currently recruiting?
Yes, NCT06678529 is actively recruiting participants. Contact the research team at 13835187186@163.com for enrollment information.
Where is the NCT06678529 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT06678529 clinical trial?
NCT06678529 is sponsored by Huazhong University of Science and Technology. The principal investigator is Hua Zheng at Huazhong University of Science and Technology. The trial plans to enroll 160 participants.