Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive transcranial magnetic stimulation, Sham stimulation.
- Who it may be relevant to
- Registry conditions: Older Patients, Cognitive Impairment, Repetitive Transcranial Magnetic Stimulation, Delayed Neurocognitive Recovery. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Repetitive Transcranial Magnetic Stimulation on Postoperative Neurocognitive Recovery in Older Patients With Preoperative Cognitive Impairment: A Randomized, Double-blinded, Sham-controlled Trial
Overview
Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.
Detailed description
Mild cognitive impairment (MCI) affects 10-15% of the population over 65 years old. In patients for elective non-cardiac and emergency surgeries, the pooled prevalences of unrecognized cognitive impairment were 37.0% and 50.0%, respectively. Patients with preoperative cognitive impairment are at increased risk of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Therefore, perioperative neurocognitive protection is particularly important for patients with preoperative cognitive impairment.
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Incidence of delayed neurocognitive recovery [Time frame: On the 5th day after surgery]
Secondary outcome measures (3)
- Incidence of delirium [Time frame: Within 5 days after surgery]
- Incidence of postoperative neurocognitive disorder at 30 days after surgery [Time frame: On the 30(±3)th day after surgery]
- Incidence of postoperative neurocognitive disorder at 180 days after surgery [Time frame: On the 180(±15)th day after surgery]
Eligibility criteria
Inclusion criteria
- Aged ≥65 years;
- Patients with preoperative mild to moderate cognitive impairment, defined as 9<Montreal Cognitive Assessment (MoCA)<26;
- Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of >2 hours;
- Expected to stay in hospital for at least 5 days after surgery.
Exclusion criteria
- Left-handed;
- Primary school education level or below;
- 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;
- Neurosurgery;
- 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);
- Other situations that are deemed unsuitable for inclusion in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 3 centers
- Peking University First Hospital — Beijing
- Peking University Shenzhen Hospital — Shenzhen
- Xijing Hospital, Air Force Medical University — Xi'an
Publications
- 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. PMID 30651152
- 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. PMID 34749047
- 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. PMID 38282693
- 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. PMID 25859906
- Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026. PMID 17640522
- 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 20 PMID 30527907
- 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. PMID 32380449
- 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. PMID 35654120
Identifiers
NCT: NCT06482749 · 2024-232