Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease

NCT06379100 | Completed

• 1 other identifier: KY20232388
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG.

Conditions

Transcranial Magnetic Stimulation; Alzheimer Disease; Magnetic Resonance Imaging; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• The changes in CDR（Clinical Dementia Rating）

  The changes in CDR-SB will constitute the major research outcome measure used to assess response to rTMS.There are two scoring methods for the CDR scale, namely Total Score Calculation (CDR-GS) and Sum of Six Content Calculation (CDR-SB). The scoring method used in this study is CDR-SB, with a total score of 18 points. The lower the score, the milder the symptoms

  baseline, 4 weeks after start of the treatment

Secondary Outcomes (9)

• The changes in MMSE(Mini Mental State Examination)

  baseline, 4 weeks and 4 weeks after treatment

• NPI (Neuropsychiatric Inventory)

  baseline, 4 weeks and 4 weeks after treatment

• ADL( Lawton-Brody Activities of Daily Living)

  baseline, 4 weeks and 4 weeks after treatment

• DST (Digital Span Test; Forward and Backward)

  baseline, 4 weeks and 4 weeks after treatment

• ADAS-cog（Alzheimer's disease assessment scale)

  baseline, 4 weeks and 4 weeks after treatment

Study Arms (2)

Transcranial Magnetic Stimulation-Real

EXPERIMENTAL

Participants will receive active TMS once daily for four weeks

Device: transcranial magnetic stimulation

Transcranial Magnetic Stimulation-Sham

SHAM COMPARATOR

Participants will receive sham TMS once daily for four weeks

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation-Real; Transcranial Magnetic Stimulation-Sham

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 45-80 years old;
• 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.
• 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

You may not qualify if:

• Central nervous system degenerative diseases other than Alzheimer's disease
• Previous history of epilepsy (excluding febrile seizures in childhood)
• 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)
• Cerebrovascular disease (excluding lacunar infarction), severe infection, malignant tumor, accompanied by severe dysfunction of organs such as heart, liver, and kidney
• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (13)

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• 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.

  PMID: 34998485 BACKGROUND

• 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.

  PMID: 29903452 BACKGROUND

• 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.

  PMID: 18835452 BACKGROUND

• 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.

  PMID: 35700915 BACKGROUND

• 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.

  PMID: 29746896 BACKGROUND

• 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.

  PMID: 20563894 BACKGROUND

• 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.

  PMID: 28987056 BACKGROUND

• 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.

  PMID: 36184623 BACKGROUND

• 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.

  PMID: 36281767 BACKGROUND

• 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.

  PMID: 31879235 BACKGROUND

• 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.

  PMID: 34752934 BACKGROUND

• 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.

  PMID: 40801847 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Wen Jiang

  The First Affiliated Hospital of Air Force Medicial University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Alzheimer's disease patients were enrolled by expert neurol ogists who were blinded to treatment allocation. rTMS sessions were performed by dedicated technicians. The Cognitive evaluations and analysis of neuro physiological data were performed by expert neurophysiologists blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 23, 2024
• Study Start: April 20, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 25, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)