Transcranial Magnetic StimulationNCT06379100
Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Alzheimer Disease, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Alzheimer Disease, Magnetic Resonance Imaging
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: A Randomized, Controlled Clinical Study on Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG.
Read the detailed description
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
- Transcranial Magnetic Stimulation, Alzheimer Disease, Magnetic Resonance Imaging, Electroencephalogram
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Intermittent Theta-Burst Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation-Real | Experimental | Participants will receive active TMS once daily for four weeks Receives: Device: transcranial magnetic stimulation |
| Transcranial Magnetic Stimulation-Sham | Sham comparator | Participants will receive sham TMS once daily for four weeks Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 4 weeks after start of the treatment
Secondary outcomes (9)
The changes in MMSE(Mini Mental State Examination)
The changes in MMSE will constitute the secondary research outcome.The full name of MMSE is mini-mental state examination. The higher the score, the better. In this study, changes in MMSE scores before and after treatment were used as secondary observations.
Measured: baseline, 4 weeks and 4 weeks after treatment
NPI (Neuropsychiatric Inventory)
The changes in NPI will constitute the secondary research outcome. The Neuropsychology Scale (NPI) evaluates 12 neuropsychiatric disorders which included 10 neuropsychiatric symptoms and 2 autonomic neurological symptoms based on the caregiver's perception of the patient's behavior and the perceived distress. The lower the score, the lighter the symptoms.
Measured: baseline, 4 weeks and 4 weeks after treatment
ADL( Lawton-Brody Activities of Daily Living)
The changes in ADL will constitute the secondary research outcome. The ADL evaluates 20 items activities of daily living which included basic life ability and instrument use ability based on the caregiver's perception of the patient's behavior. The lower the score, the lighter the symptoms.
Measured: baseline, 4 weeks and 4 weeks after treatment
DST (Digital Span Test; Forward and Backward)
The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability.
Measured: baseline, 4 weeks and 4 weeks after treatment
ADAS-cog（Alzheimer's disease assessment scale)
The changes in ADAS-cog will constitute the secondary research outcome. The lower the score, the lighter the symptoms.
Measured: baseline, 4 weeks and 4 weeks after treatment
DMS(Delayed matching-to-sample task)
The DMS paradigm is a commonly used paradigm for studying working memory. This study, combined with EEG monitoring, can investigate the changes in the encoding, maintenance, and retrieval phases of working memory.The changes in DMS will constitute the secondary research outcome.
Measured: baseline, 4 weeks and 4 weeks after treatment
MEP（Motor evoked potential）
MEP is a muscle motor complex potential recorded by stimulating the motor cortex in the contralateral target muscle; Check the overall synchronization and integrity of the transmission and transmission pathways of motor nerves from the cortex to the muscles.The changes in MEP will constitute the secondary research outcome.
Measured: baseline, 4 weeks and 4 weeks after treatment
MRI measures
This study mainly applied resting blood oxygen level dependent functional magnetic resonance imaging (BOLD), arterial spin labeling (ASL), and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellar dentate nucleus in healthy subjects and patients before and after 4 weeks of TMS treatment, as well as the changes in the cerebellar cortical white matter fiber bundles one month after treatment.
Measured: baseline, 4 weeks and 4 weeks after treatment
EEG（electroencephalogram）
Use electroencephalography to record resting state electroencephalograms before and after treatment, as well as during follow-up, as well as TMS synchronized electroencephalograms stimulated by single pulse TMS in the bilateral cerebellar dentate nucleus, and task state electroencephalograms during DMS paradigm. Analyzing changes in power spectrum, neural oscillations, and functional connectivity of EEG data before and after treatment and during follow-up
Measured: baseline, 4 weeks and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start20 Apr 2024
- Primary completion1 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, Study chair, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379100
- Sponsor's protocol ID
- KY20232388
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34902823GBD 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.
PubMed 34998485Stoodley 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.
PubMed 29903452Stoodley 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.
PubMed 18835452Yao 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.
PubMed 35700915Beckinghausen 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.
PubMed 29746896Marvel 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.
PubMed 20563894Starowicz-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.
PubMed 28987056Wu 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.
PubMed 36184623Koch 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.
PubMed 36281767Sabbagh 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.
PubMed 31879235Wu 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.
PubMed 34752934Zhang 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.
PubMed 40801847
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study on Cerebellar ITBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06379100
- Acronym / sponsor ID
- KY20232388
- Conditions
- Transcranial Magnetic Stimulation, Alzheimer Disease, Magnetic Resonance Imaging, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation-Real | Experimental | Device: transcranial magnetic stimulationParticipants will receive active TMS once daily for four weeks |
| Transcranial Magnetic Stimulation-Sham | Sham comparator | Device: transcranial magnetic stimulationParticipants will receive sham TMS once daily for four weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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
Key exclusion criteria (10 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationIntermittent Theta-Burst Transcranial Magnetic Stimulation | Device | Transcranial Magnetic Stimulation-Real, Transcranial Magnetic Stimulation-Sham |
Primary outcome
The changes in CDR（Clinical Dementia Rating）
Time frame: baseline, 4 weeks after start of the treatment
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
9 secondary outcomes
The changes in MMSE(Mini Mental State Examination)
Time frame: baseline, 4 weeks and 4 weeks after treatment
NPI (Neuropsychiatric Inventory)
Time frame: baseline, 4 weeks and 4 weeks after treatment
ADL( Lawton-Brody Activities of Daily Living)
Time frame: baseline, 4 weeks and 4 weeks after treatment
DST (Digital Span Test; Forward and Backward)
Time frame: baseline, 4 weeks and 4 weeks after treatment
ADAS-cog（Alzheimer's disease assessment scale)
Time frame: baseline, 4 weeks and 4 weeks after treatment
DMS(Delayed matching-to-sample task)
Time frame: baseline, 4 weeks and 4 weeks after treatment
MEP（Motor evoked potential）
Time frame: baseline, 4 weeks and 4 weeks after treatment
MRI measures
Time frame: baseline, 4 weeks and 4 weeks after treatment
EEG（electroencephalogram）
Time frame: baseline, 4 weeks and 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 34902823Xue 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.
- Background: PubMed 34998485GBD 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.
- Background: PubMed 29903452Stoodley 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.
- Background: PubMed 18835452Stoodley 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.
- Background: PubMed 35700915Yao 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.
- Background: PubMed 29746896Beckinghausen 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.
- Background: PubMed 20563894Marvel 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.
- Background: PubMed 28987056Starowicz-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.
- Background: PubMed 36184623Wu 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.
- Background: PubMed 36281767Koch 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.
- Background: PubMed 31879235Sabbagh 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.
- Background: PubMed 34752934Wu 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.
- Individual participant dataSharing planned: No
Related trials for Transcranial Magnetic Stimulation
Recruiting
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Modeling of Recruitment Curves
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Jiang study chair
The First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Alzheimer Disease, run by Xijing Hospital at 1 site 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in CDR（Clinical Dementia Rating） (time frame: baseline, 4 weeks after start of the treatment). 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 NCT06379100, which also lists 13 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 15 Oct 2024.