An interventional study of Transcranial photobiomodulation therapy and Transcranial pseudo-photobiomodulation in Older Adults, Surgery and Transcranial Photobiomodulation, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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.
Along with the aging population, the number of older adults undergoing surgery is increasing. Neurocognitive complications (such as delirium and delayed neurocognitive recovery) are common in older patients after surgery, especially those with pre-existing neurocognitive decline. Occurrence of neurocognitive complications are associated with wose early and long-term outcomes.
Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. Study results in healthy volunteers showed favorable effects on neurocognitive functions. This technique has been safely used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. Transcranial photobiomodulation therapy may reduce postopeative neurocognitive complications in high risk patients but evience is limited.
This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce neurocognitive complications in older patients with pre-existing neurocognitive impairment. The primary endpoint is delayed neurocognitive recovery; secondary endpoints include postoperative delirium.
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Exclusion Criteria:
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
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
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.
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.
Incidence of delayed neurocognitive recovery
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).
Time frame: On the 4th day after surgery or before discharge if earlier
Incidence of postoperative delirium
Delirium will be assessed twice daily (8-10 am and 6-8 pm) using the 3-Dimensional Confusion Assessment Method (3D-CAM) for patients without intubation or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for patients with intubation.
Time frame: Up to 3 days after surgery
Incidence of postoperative neurocognitive disorder
Cognitive function will be assessed at baseline and at 30 days after surgery using the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitive function). Postoperative neurocognitive disorder (pNCD) is defined as: a \|Z\| value of decline in MoCA score ≥1.96. Z value = \[(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the nonsurgical group)\] / (standard deviation of change from baseline in MoCA score in the non-surgical group).
Time frame: At 30 days after surgery
Early postoperative pain intensity
Pain intensity will be assessed twice daily (8-10 am and 6-8 pm) both at rest and with movement (coughing or turning over) using an 11-point Numeric Rating Scale (NRS; scores range from 0 to 10 where 0=no pain and 10=the worst pain).
Time frame: Up to 3 days after surgery
Early postoperative subjective sleep quality
Subjective sleep quality will be assessed once daily (8-10 am) using an 11-point Numeric Rating Scale (NRS; scores range from 0 to 10 where 0=the best sleep and 10=the worst sleep.
Time frame: Up to nights after surgery3
Hospital stay after surgery
From the day of surgery until the day of hospital discharge.
Time frame: Up to 30 days after surgery
Postopeative complications within 30 days
Postoperative complications are defined as new-onset conditions that are deemed harmful and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification.
Time frame: Up to 30 days after surgery
Plan to share: No
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Peking University First Hospital