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Recruiting Not applicable

Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

NCT07736092 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-08-05
Last updated
2026-08-10

Condition(s) studied

Older AdultsSurgeryTranscranial PhotobiomodulationDelayed Neurocognitive RecoveryPostoperative Delirium

Investigational drug(s) / intervention(s)

Transcranial photobiomodulation therapyTranscranial pseudo-photobiomodulation

Transcranial photobiomodulation therapy: A transcranial photobiomodulation therapy device employing medium-intensity LED near-infrared light will be applied to the foreheads 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 treatments. Each intervention will last 10 minutes. The investigators conducting the bedside intervention will monitor the safety of participants during the interventions.

Transcranial pseudo-photobiomodulation: A transcranial photobiomodulation therapy device employing extremely low-intensity LED near-infrared light will be applied to the foreheads 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 treatments. Each intervention will last 10 minutes. The investigators conducting the bedside intervention will monitor the safety of participants during the interventions.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Incidence of delayed neurocognitive recovery — On the 4th day after surgery or before discharge if earlier
    Cognitive function will be assessed at baseline and at 4 days after surgery (or before hospital discharge if ealier) using the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitive function). Delayed neurocognitive decline (dNCR) is defined as: a \|Z\| value of decline in MoCA score ≥1.96. Z value = \[(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the non-surgical group)\] / (standard deviation of change from baseline in MoCA score in the non-surgical group).

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07736092 on ClinicalTrials.gov ↗ ← All trials in China