Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients | NCT07736092

NCT07736092

Overview

NCT ID: NCT07736092
Lead Sponsor: Peking University First HospitalOTHER
Official Title: Impact of Perioperative Transcranial Photobiomodulation on Delayed Neurocognitive Recovery in Older Patients After Surgery: a Randomized, Double-blind, Pseudo-modulation-controlled Preliminary Clinical Trial
Brief Summary: Delayed neurocognitive recovery is a common neurocognitive complication in older patients after surgery, especially those with preoperative neurocognitive decline. Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. This technique has been used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce the incidence of delayed neurocognitive recovery in older patients with pre-existing neurocognitive impairment.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jul 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 130Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Ya-Wei Li, MDContact
liyawei@bjmu.edu.cn086-010-83575138

Similar Studies

Participant Group/Arms

Intervention GroupExperimental

A transcranial photobiomodulation therapy device employing medium-intensity LED near-infrared light will be applied to the forehead of participants. Treatments will be done twice daily on the day before surgery and on the first and second days after surgery, and once on the day of surgery, with at least 8 hours between any two interventions.

Device: Transcranial photobiomodulation therapy

Controll GroupSham Comparator

A transcranial photobiomodulation therapy device employing extremely low-intensity LED near-infrared light will be applied to the forehead of participants. Treatments will be done twice daily on the day before surgery and on the first and second days after surgery, and once on the day of surgery, with at least 8 hours between any two interventions.

Device: Transcranial pseudo-photobiomodulation