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NCT Number: NCT07736092

Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

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.

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Key information

Conditions

Older Adults Confusion Delayed Neurocognitive Recovery Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms Surgery Transcranial Photobiomodulation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial photobiomodulation therapy

Device

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

Device

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.

Primary outcomes

  1. Incidence of delayed neurocognitive recovery

    Time frame: 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).

Secondary outcomes

  1. Incidence of postoperative delirium

    Time frame: Up to 3 days after surgery

    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.

  2. Incidence of postoperative neurocognitive disorder

    Time frame: At 30 days after surgery

    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).

Other outcomes

  1. Early postoperative pain intensity

    Time frame: Up to 3 days after surgery

    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).

  2. Early postoperative subjective sleep quality

    Time frame: Up to nights after surgery3

    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.

  3. Hospital stay after surgery

    Time frame: Up to 30 days after surgery

    From the day of surgery until the day of hospital discharge.

  4. Postopeative complications within 30 days

    Time frame: Up to 30 days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ya-Wei Li, MD

CONTACT

[email protected]

086-010-83575138

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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