Delayed Neurocognitive Recovery, Older Adults, Postoperative Delirium, Surgery, Transcranial Photobiomodulation
Conditions
Keywords
Older adults, Surgery, Transcranial photobiomodulation, Delayed neurocognitive recovery, Postoperative delirium
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.
Detailed description
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.
Interventions
DEVICETranscranial 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.
DEVICETranscranial 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.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | 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. |
| Incidence of postoperative neurocognitive disorder | 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). |
Countries
China
Contacts
CONTACTYa-Wei Li, MD
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD
Peking University First Hospital
Outcome results
None listed