Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

Официальное название

Impact of Perioperative Transcranial Photobiomodulation on Delayed Neurocognitive Recovery in Older Patients After Surgery: a Randomized, Double-blind, Pseudo-modulation-controlled Preliminary Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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 interv

Первичные конечные точки

• Incidence of delayed neurocognitive recovery [Срок оценки: On the 4th day after surgery or before discharge if earlier]

Вторичные конечные точки (2)

• Incidence of postoperative delirium [Срок оценки: Up to 3 days after surgery]
• Incidence of postoperative neurocognitive disorder [Срок оценки: At 30 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Публикации

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• Vacas S, Canales C, Deiner SG, Cole DJ. Perioperative Brain Health in the Older Adult: A Patient Safety Imperative. Anesth Analg. 2022 Aug 1;135(2):316-328. doi: 10.1213/ANE.0000000000006090. Epub 2022 May 18. PMID 35584550
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• Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, A PMID 31166241

Идентификаторы

NCT: NCT07736092 · 2026R0444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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