Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
NCT ID: NCT06379100
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-04-20
2024-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Transcranial Magnetic Stimulation-Real
Participants will receive active TMS once daily for four weeks
transcranial magnetic stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation-Sham
Participants will receive sham TMS once daily for four weeks
transcranial magnetic stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Interventions
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transcranial magnetic stimulation
Intermittent Theta-Burst Transcranial Magnetic Stimulation
Eligibility Criteria
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Inclusion Criteria
2. Meets the NIA-AA standards established by the National Institute on Aging in the United States; Cerebrospinal fluid presents as A β decrease and increase tau protein.
3 The MMSE score ranges from 18 to 26, and the Clinical Dementia Rating (CDR) score is 0.5 to 1 4 At least one adult caregiver 5 patients have received treatment with acetylcholinesterase inhibitors (AChEI) or memantine, such as donepezil, galantamine, or gabalin
* Medication for at least 3 months
* The current dosing regimen remains stable for 8 weeks
* The medication plan remains stable throughout the entire process 6. At least 8 years of educational experience 7 Patients and their families voluntarily sign informed consent forms
Exclusion Criteria
2. Previous history of epilepsy (excluding febrile seizures in childhood)
3. According to the Diagnostic and Statistical Manual of Mental Disorders, the Fourth Edition - Text Revised Edition (DSM IV-TR) standard meets any of the following:
* Depression (currently)
* Schizophrenia
* Other psychiatric disorders, bipolar disorder, or substance dependence (including alcohol) (within the past 5 years)
4. Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney
5. There are contraindications for transcranial magnetic stimulation and MRI, or there are metal or implanted devices in the body, such as pacemakers, deep brain stimulators, etc; 6 Use any of the following medications for treatment within the past 3 months:
* Typical and atypical antipsychotic drugs (such as clozapine, olanzapine)
* Antiepileptic drugs (such as carbamazepine, topiramate, sodium valproate) 7 has received TMS treatment in the past 8 Participate in clinical trials of any drug within 6 months prior to study registration
45 Years
80 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Wen Jiang
Role: STUDY_CHAIR
The First Affiliated Hospital of Air Force Medicial University
Locations
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Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
Countries
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References
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Xue T, Wu X, Chen S, Yang Y, Yan Z, Song Z, Zhang W, Zhang J, Chen Z, Wang Z. The efficacy and safety of dual orexin receptor antagonists in primary insomnia: A systematic review and network meta-analysis. Sleep Med Rev. 2022 Feb;61:101573. doi: 10.1016/j.smrv.2021.101573. Epub 2021 Nov 26.
GBD 2019 Dementia Forecasting Collaborators. Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2022 Feb;7(2):e105-e125. doi: 10.1016/S2468-2667(21)00249-8. Epub 2022 Jan 6.
Stoodley CJ, Schmahmann JD. Functional topography of the human cerebellum. Handb Clin Neurol. 2018;154:59-70. doi: 10.1016/B978-0-444-63956-1.00004-7.
Stoodley CJ, Schmahmann JD. Functional topography in the human cerebellum: a meta-analysis of neuroimaging studies. Neuroimage. 2009 Jan 15;44(2):489-501. doi: 10.1016/j.neuroimage.2008.08.039. Epub 2008 Sep 16.
Yao Q, Tang F, Wang Y, Yan Y, Dong L, Wang T, Zhu D, Tian M, Lin X, Shi J. Effect of cerebellum stimulation on cognitive recovery in patients with Alzheimer disease: A randomized clinical trial. Brain Stimul. 2022 Jul-Aug;15(4):910-920. doi: 10.1016/j.brs.2022.06.004. Epub 2022 Jun 11.
Beckinghausen J, Sillitoe RV. Insights into cerebellar development and connectivity. Neurosci Lett. 2019 Jan 1;688:2-13. doi: 10.1016/j.neulet.2018.05.013. Epub 2018 May 7.
Marvel CL, Desmond JE. Functional topography of the cerebellum in verbal working memory. Neuropsychol Rev. 2010 Sep;20(3):271-9. doi: 10.1007/s11065-010-9137-7. Epub 2010 Jun 22.
Starowicz-Filip A, Chrobak AA, Moskala M, Krzyzewski RM, Kwinta B, Kwiatkowski S, Milczarek O, Rajtar-Zembaty A, Przewoznik D. The role of the cerebellum in the regulation of language functions. Psychiatr Pol. 2017 Aug 29;51(4):661-671. doi: 10.12740/PP/68547. Epub 2017 Aug 29. English, Polish.
Wu C, Yang L, Feng S, Zhu L, Yang L, Liu TC, Duan R. Therapeutic non-invasive brain treatments in Alzheimer's disease: recent advances and challenges. Inflamm Regen. 2022 Oct 3;42(1):31. doi: 10.1186/s41232-022-00216-8.
Koch G, Casula EP, Bonni S, Borghi I, Assogna M, Minei M, Pellicciari MC, Motta C, D'Acunto A, Porrazzini F, Maiella M, Ferrari C, Caltagirone C, Santarnecchi E, Bozzali M, Martorana A. Precuneus magnetic stimulation for Alzheimer's disease: a randomized, sham-controlled trial. Brain. 2022 Nov 21;145(11):3776-3786. doi: 10.1093/brain/awac285.
Sabbagh M, Sadowsky C, Tousi B, Agronin ME, Alva G, Armon C, Bernick C, Keegan AP, Karantzoulis S, Baror E, Ploznik M, Pascual-Leone A. Effects of a combined transcranial magnetic stimulation (TMS) and cognitive training intervention in patients with Alzheimer's disease. Alzheimers Dement. 2020 Apr;16(4):641-650. doi: 10.1016/j.jalz.2019.08.197. Epub 2020 Jan 16.
Wu X, Ji GJ, Geng Z, Wang L, Yan Y, Wu Y, Xiao G, Gao L, Wei Q, Zhou S, Wei L, Tian Y, Wang K. Accelerated intermittent theta-burst stimulation broadly ameliorates symptoms and cognition in Alzheimer's disease: A randomized controlled trial. Brain Stimul. 2022 Jan-Feb;15(1):35-45. doi: 10.1016/j.brs.2021.11.007. Epub 2021 Nov 6.
Zhang X, Sun Z, Wu D, Shi X, Song C, Guan X, Hao J, Guo Y, Wang X, Wei D, Liu Z, Zhao J, Jiang W. Effects of cerebellar intermittent theta-burst stimulation on patients with Alzheimer's disease: A randomized controlled trial. J Alzheimers Dis. 2025 Oct;107(3):1187-1199. doi: 10.1177/13872877251366656. Epub 2025 Aug 13.
Other Identifiers
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KY20232388
Identifier Type: -
Identifier Source: org_study_id
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