Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking University First Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Controll GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

1

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
2

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
3

Hospital stay after surgery

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

Time frame
Up to 30 days after surgery
4

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

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