AzTrials
AzTrials

Older PatientsNCT06482749

Repetitive Transcranial Magnetic Stimulation and Postoperative Neurocognitive Recovery

A study testing Repetitive transcranial magnetic stimulation in people with Older Patients and Cognitive Impairment, run by Peking University First Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Repetitive transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
568 participants
Where
3 sitesChina
Study dates
28 Jul 2025to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD, PhD contact

8610 83572784

wangdongxin@hotmail.com

China3 sites, 3 recruiting
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PhD, 8610 83572784, wangdongxin@hotmail.com

    Hao Kong, MD, 8610 83575138, konghao2438@126.com

    Recruiting
  • Peking University Shenzhen Hospital

    Shenzhen, Guangzhou, 516473

    Tao Luo, MD, 0755 83923333, luotao_wh@yahoo.com

    Tao Luo, MD

    Not yet recruiting
  • Xijing Hospital, Air Force Medical University

    Xi'an, Shannxi, 710032

    Zhi-Hong Lu, MD, PhD, deerlu23@163.com

    Zhi-Hong Lu, MD, PhD

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Repetitive transcranial magnetic stimulation, Sham stimulation
Keywords
Older patients, Cognitive impairment, Repetitive transcranial magnetic stimulation, Delayed neurocognitive recovery, Postoperative neurocognitive disorder
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive transcranial magnetic stimulationDevice

    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 stimulationDevice

    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.

Study groups in NCT06482749
Study groupRoleWhat they receive
Repetitive Transcranial Magnetic Stimulation GroupExperimentalRepeated 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.
Receives: Device: Repetitive transcranial magnetic stimulation
Sham Stimulation GroupSham comparatorSham 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.
Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of delayed neurocognitive recovery

    Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher score indicating better function) before surgery and at 5 days after surgery. A MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of delayed neurocognitive recovery.

    Measured: On the 5th day after surgery

Secondary outcomes (3)
  1. Incidence of delirium

    Delirium is assessed with the 3D-Confusion Assessment Method (for non-intubated patients) or Confusion Assessment Method for the Intensive Care Unit (for intubated patients) twice daily (8-10 am and 4-6 pm).

    Measured: Within 5 days after surgery

  2. Incidence of postoperative neurocognitive disorder at 30 days after surgery

    Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 30±3 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.

    Measured: On the 30(±3)th day after surgery

  3. Incidence of postoperative neurocognitive disorder at 180 days after surgery

    Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 180±15 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.

    Measured: On the 180(±15)th day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start28 Jul 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
568 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06482749
Sponsor's protocol ID
2024-232
Status last verified
Jul 2025
First submitted
23 Jun 2024
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25859906
  • Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.

    PubMed 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 2018 Dec 3.

    PubMed 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.

    PubMed 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.

    PubMed 35654120
  • 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.

    PubMed 23194830
  • 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.

    PubMed 29326021
  • 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.

    PubMed 20493761
  • 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.

    PubMed 28614399
  • 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.

    PubMed 31783330
  • 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.

    PubMed 36215904
  • 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.

    PubMed 37004840

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive transcranial magnetic stimulation in people with Older Patients and Cognitive Impairment, run by Peking University First Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD, PhD (8610 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delayed neurocognitive recovery (time frame: On the 5th day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06482749, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in