Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery
NCT ID: NCT06482749
Last Updated: 2025-07-31
Study Results
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Basic Information
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RECRUITING
NA
568 participants
INTERVENTIONAL
2025-07-28
2029-02-28
Brief Summary
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Detailed Description
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Repetitive transcranial magnetic stimulation (rTMS) is a neural modulation technique. By acting on the brain and altering the membrane potential of cortical neurons, the generated pulsed magnetic fields affect neural metabolism and electrical activity and trigger a series of physiological and biochemical reactions. It was found that high frequency (\>5 Hz) rTMS increases cortical excitability, whereas low frequency (\<1Hz) rTMS reduces corticol excitability. The mechanism by which rTMS regulates brain function is generally believed to be related to the long-term enhancement and long-term inhibition of synaptic transmission function.
The left dorsolateral prefrontal cortex (DLPFC) is an important target of rTMS intervention for improving cognitive function. A meta-analysis showed that high-frequency rTMS on the DLPFC and low-frequency rTMS on the right medial prefrontal cortex improved memory function; high frequency rTMS on the right inferior frontal gyrus enhanced executive ability in non-surgical patients with mild cognitive impairment or Alzheimer's disease. Another meta-analysis showed that high-frequency rTMS on DLPFC is an effective therapeutic option for improving cognitive function in Alzheimer patients.
This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Repetitive Transcranial Magnetic Stimulation Group
Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Repetitive transcranial magnetic stimulation
Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Sham Stimulation Group
Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Sham stimulation
Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Interventions
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Repetitive transcranial magnetic stimulation
Repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Sham stimulation
Sham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Patients with preoperative mild to moderate cognitive impairment, defined as 9\<Montreal Cognitive Assessment (MoCA)\<26;
3. Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of \>2 hours;
4. Expected to stay in hospital for at least 5 days after surgery.
Exclusion Criteria
2. Primary school education level or below;
3. Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;
4. Neurosurgery;
5. Presence of contraindications to rTMS treatment, including epilepsy, pregnant or lactating women, or with a metal or electric implanted device (e.g., deep brain stimulator, ventriculoperitoneal shunt, aneurysm clip, pacemaker, cochlear implant, or surgical staples on the scalp);
6. Other situations that are deemed unsuitable for inclusion in the study.
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Air Force Medicial University
OTHER
Peking University Shenzhen Hospital
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Shenzhen Hospital
Shenzhen, Guangzhou, China
Xijing Hospital, Air Force Medical University
Xi'an, Shannxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Anderson ND. State of the science on mild cognitive impairment (MCI). CNS Spectr. 2019 Feb;24(1):78-87. doi: 10.1017/S1092852918001347. Epub 2019 Jan 17.
Kapoor P, Chen L, Saripella A, Waseem R, Nagappa M, Wong J, Riazi S, Gold D, Tang-Wai DF, Suen C, Englesakis M, Norman R, Sinha SK, Chung F. Prevalence of preoperative cognitive impairment in older surgical patients.: A systematic review and meta-analysis. J Clin Anesth. 2022 Feb;76:110574. doi: 10.1016/j.jclinane.2021.110574. Epub 2021 Nov 5.
Park S, Kim J, Ha Y, Kim KN, Yi S, Koo BN. Preoperative mild cognitive impairment as a risk factor of postoperative cognitive dysfunction in elderly patients undergoing spine surgery. Front Aging Neurosci. 2024 Jan 12;16:1292942. doi: 10.3389/fnagi.2024.1292942. eCollection 2024.
Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.
Du J, Yang F, Hu J, Hu J, Xu Q, Cong N, Zhang Q, Liu L, Mantini D, Zhang Z, Lu G, Liu X. Effects of high- and low-frequency repetitive transcranial magnetic stimulation on motor recovery in early stroke patients: Evidence from a randomized controlled trial with clinical, neurophysiological and functional imaging assessments. Neuroimage Clin. 2019;21:101620. doi: 10.1016/j.nicl.2018.101620. Epub 2018 Dec 3.
Wang Q, Zhang D, Zhao YY, Hai H, Ma YW. Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial. Brain Stimul. 2020 Jul-Aug;13(4):979-986. doi: 10.1016/j.brs.2020.03.020. Epub 2020 Apr 2.
Chen Q, Shen W, Sun H, Zhang H, Liu C, Chen Z, Yu L, Cai X, Ke J, Li L, Zhang L, Fang Q. The effect of coupled inhibitory-facilitatory repetitive transcranial magnetic stimulation on shaping early reorganization of the motor network after stroke. Brain Res. 2022 Sep 1;1790:147959. doi: 10.1016/j.brainres.2022.147959. Epub 2022 May 30.
Gaudeau-Bosma C, Moulier V, Allard AC, Sidhoumi D, Bouaziz N, Braha S, Volle E, Januel D. Effect of two weeks of rTMS on brain activity in healthy subjects during an n-back task: a randomized double blind study. Brain Stimul. 2013 Jul;6(4):569-75. doi: 10.1016/j.brs.2012.10.009. Epub 2012 Nov 19.
Alcala-Lozano R, Morelos-Santana E, Cortes-Sotres JF, Garza-Villarreal EA, Sosa-Ortiz AL, Gonzalez-Olvera JJ. Similar clinical improvement and maintenance after rTMS at 5 Hz using a simple vs. complex protocol in Alzheimer's disease. Brain Stimul. 2018 May-Jun;11(3):625-627. doi: 10.1016/j.brs.2017.12.011. Epub 2017 Dec 29.
Bressler SL, Menon V. Large-scale brain networks in cognition: emerging methods and principles. Trends Cogn Sci. 2010 Jun;14(6):277-90. doi: 10.1016/j.tics.2010.04.004. Epub 2010 May 20.
Li Y, Wang L, Jia M, Guo J, Wang H, Wang M. The effects of high-frequency rTMS over the left DLPFC on cognitive control in young healthy participants. PLoS One. 2017 Jun 14;12(6):e0179430. doi: 10.1371/journal.pone.0179430. eCollection 2017.
Chou YH, Ton That V, Sundman M. A systematic review and meta-analysis of rTMS effects on cognitive enhancement in mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2020 Feb;86:1-10. doi: 10.1016/j.neurobiolaging.2019.08.020. Epub 2019 Aug 27.
Simko P, Kent JA, Rektorova I. Is non-invasive brain stimulation effective for cognitive enhancement in Alzheimer's disease? An updated meta-analysis. Clin Neurophysiol. 2022 Dec;144:23-40. doi: 10.1016/j.clinph.2022.09.010. Epub 2022 Sep 28.
Gao Y, Qiu Y, Yang Q, Tang S, Gong J, Fan H, Wu Y, Lu X. Repetitive transcranial magnetic stimulation combined with cognitive training for cognitive function and activities of daily living in patients with post-stroke cognitive impairment: A systematic review and meta-analysis. Ageing Res Rev. 2023 Jun;87:101919. doi: 10.1016/j.arr.2023.101919. Epub 2023 Mar 31.
Chu CS, Li CT, Brunoni AR, Yang FC, Tseng PT, Tu YK, Stubbs B, Carvalho AF, Thompson T, Rajji TK, Yeh TC, Tsai CK, Chen TY, Li DJ, Hsu CW, Wu YC, Yu CL, Liang CS. Cognitive effects and acceptability of non-invasive brain stimulation on Alzheimer's disease and mild cognitive impairment: a component network meta-analysis. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):195-203. doi: 10.1136/jnnp-2020-323870. Epub 2020 Oct 28.
Miller A, Allen RJ, Juma AA, Chowdhury R, Burke MR. Does repetitive transcranial magnetic stimulation improve cognitive function in age-related neurodegenerative diseases? A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2023 Aug;38(8):e5974. doi: 10.1002/gps.5974.
Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Propofol compared with sevoflurane general anaesthesia is associated with decreased delayed neurocognitive recovery in older adults. Br J Anaesth. 2018 Sep;121(3):595-604. doi: 10.1016/j.bja.2018.05.059. Epub 2018 Jul 27.
Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
Other Identifiers
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2024-232
Identifier Type: -
Identifier Source: org_study_id
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