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

NCT ID: NCT06379100

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2024-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study intends to apply intermittent therapy for the first time θ The Outbreak Stimulation (iTBS) mode was used for rTMS treatment in the cerebellum of Alzheimer's disease (AD). This was a randomized, double-blind, parallel, and sham stimulation controlled clinical trial, which included 28 AD patients. All patients were randomly divided into the iTBS group and the sham stimulation group. Collect clinical information, scales, magnetic resonance imaging, TMS synchronous electroencephalography, polysomnography monitoring, etc., and then perform TMS/false stimulation treatment on subjects for 4 weeks (a total of 20 times); After treatment and one month follow-up, relevant scales, magnetic resonance imaging, TMS synchronous electroencephalogram and other data were collected again, and appropriate statistical methods were used to analyze the therapeutic effect.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transcranial Magnetic Stimulation Alzheimer Disease Magnetic Resonance Imaging Electroencephalogram

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transcranial Magnetic Stimulation-Real

Participants will receive active TMS once daily for four weeks

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type DEVICE

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation-Sham

Participants will receive sham TMS once daily for four weeks

Group Type SHAM_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcranial magnetic stimulation

Intermittent Theta-Burst Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age: 45-80 years old;
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

1. Central nervous system degenerative diseases other than Alzheimer's disease
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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wen Jiang

Role: STUDY_CHAIR

The First Affiliated Hospital of Air Force Medicial University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34902823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34998485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29903452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18835452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35700915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29746896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20563894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28987056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36184623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36281767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31879235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34752934 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40801847 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20232388

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.