Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

Official 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

Overview

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

• Device 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
• Device 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

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Peking University First Hospital — Beijing

Publications

• Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15. PMID 30336844
• 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
• Fenta E, Teshome D, Kibret S, Hunie M, Tiruneh A, Belete A, Molla A, Dessie B, Geta K. Incidence and risk factors of postoperative delirium in elderly surgical patients 2023. Sci Rep. 2025 Jan 9;15(1):1400. doi: 10.1038/s41598-024-84554-2. PMID 39789093
• Kong H, Xu LM, Wang DX. Perioperative neurocognitive disorders: A narrative review focusing on diagnosis, prevention, and treatment. CNS Neurosci Ther. 2022 Aug;28(8):1147-1167. doi: 10.1111/cns.13873. Epub 2022 Jun 1. PMID 35652170
• Alhamdah Y, Li WY, Nagappa M, Yan E, He D, Sarieplla A, Englesakis M, Elias Z, Chan MTV, Wang DX, Chung F. Perioperative approaches to prevent delayed neurocognitive recovery and postoperative neurocognitive disorder in older surgical patients: A systematic review and meta-analysis of randomized controlled trials. J Anaesthesiol Clin Pharmacol. 2025 Jan-Mar;41(1):3-14. doi: 10.4103/joacp.joacp_396 PMID 40026724
• Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. L PMID 9525362
• Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e. PMID 18156878
• 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

Identifiers

NCT: NCT07736092 · 2026R0444

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗