Perioperative transcranial photobiomodulation to see if it helps older adults recover brain function after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether perioperative transcranial photobiomodulation can reduce delayed neurocognitive recovery and postoperative delirium in adults aged 65 and older with pre-existing cognitive impairment. Participants undergoing non-cardiac, non-neurosurgical procedures under general anesthesia will receive transcranial photobiomodulation or a sham/alternative method during the perioperative period. Primary outcome is delayed neurocognitive recovery, with postoperative delirium as a secondary endpoint. The approach builds on prior safety data and exploratory findings in other populations, aiming to improve postoperative brain outcomes in high-risk older adults.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 65 years or older.
* Preoperative Mini-Mental State Examination (MMSE) \<27.
* Scheduled to undergo non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \>1 hour.
* Planned hospital stay of at least 1 day before surgery and at least 2 days after surgery.

Exclusion Criteria:

* Communication barriers before surgery due to coma, severe dementia, or language disorders.
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or delirium before surgery.
* History of brain injury, tumors, or surgery, or intracranial metal implants, or skin or soft tissue injuries on the head or face.
* History of ischemic or hemorrhagic stroke within 3 months before surgery.
* An American Society of Anesthesiologists class ≥ IV.
* Enrolled in other interventional studies.
* Other conditions deemed unsuitable for study participation.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Ya-Wei Li, MD
• Email: liyawei@bjmu.edu.cn
• Phone: 086-010-83575138

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.