Alzheimer DiseaseNCT06669182
Advantage of Cerebellar Transcranial Magnetic Stimulation in Alzheimer's Diseases （ACT-AD）
A study testing Intermittent Theta-Burst Transcranial Magnetic Stimulation in people with Alzheimer Disease and Transcranial Magnetic Stimulation, run by Xijing Hospital at 4 sites in China.
Trial summary
Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, Transcranial Magnetic Stimulation, Cerebellum
- What is being tested?
- Intermittent Theta-Burst Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 7 Jan 2025to 10 Apr 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50-85 years old
- Meet the core clinical criteria of NIA-AA for possible Alzheimer's disease dementia, and PET or cerebrospinal fluid markers show elevated p-tau and decreased A β (1-42)
- MMSE score ranges from 18-26 points; CDR score 0.5-1 points
- The patient has received treatment with acetylcholinesterase inhibitors (AChEI), NMDA receptor antagonists, or mannequine therapy, and the current dosing regimen has remained stable for the 12 weeks prior to baseline assessment
- At least one adult caregiver
- The patient or legal guardian voluntarily signs the informed consent form
Who cannot join
- Neurodegenerative disorders other than AD.
- Significant intracranial focal or vascular pathology seen on brain MRI scan
- History of seizure (with the exception of febrile seizures in childhood)
- Any of the following psychotic disorders (DSM IV-TR criteria):
- Major depressive disorder (current)
- Schizophrenia
Show all 12Show fewer
- Other psychotic disorders, bipolar disorder, or substance related disorders (within the past 5 years)
- GDS score ≥ 8 points in baseline assessment
- Cerebrovascular disease, severe infection, malignant tumor, or severe dysfunction of organs such as heart, liver, and kidney.
- Pregnant or lactating women
- Contraindications for TMS or MRI, metal or implanted devices in the body (such as pacemakers, deep brain stimulators).
- Participate in AD related clinical trials within 6 months prior to research registration
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Wen Jiang, 86-13991905538, jiangwen@fmmu.edu.cn
Xin Zhang, 86-13154378732, zhangxin316@fmmu.edu.cn
- Recruiting
Tangdu Hospital of Air Force Military Medical University
Xi'an, Shannxi
Wei Zhang, 86-17392985036, tdzw@fmmu.edu.cn
- Recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shannxi
Bei Zhang, 86-13772545002, bud8092doc@163.com
- Recruiting
The Third Hospital of Xi'an
Xi'an, Shannxi
Gejuan Zhang, 86-17306582148, zhanggejuan@163.com
About this study
Official title: Effects of Cerebellar Transcranial Magnetic Stimulation on Patients With Alzheimer's Disease：A Multicenter Randomized Controlled Trial
Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. This study will be conducted to evaluate the efficacy and safety of cerebellar Intermittent theta-burst stimulation (CRB-iTBS) in participants with mild Alzheimer's disease on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 3 months of treatment in the Core Study. This project aims to provide a valid treatment to improve the cognitive function and quality of life for those with Alzheimer's disease.
Read the detailed description
Background:
Alzheimer's disease (AD) is a progressive neurodegenerative disease that poses substantial challenges for both families and society. The primary pathological hallmarks of AD are β-amyloid plaque (Aβ) deposition and neurofibrillary tangles. Notably, the cerebellum seems to be resilient to these pathological developments in the initial phases of AD. This early resistance of the cerebellum suggests it might contribute to compensating for the cognitive impairments associated with AD. Enhancing cerebellar reserve is a potential therapeutic approach. Repetitive transcranial magnetic stimulation (rTMS) has been explored as a means to achieve this, attributed to synaptic plasticity in the cerebellar cortex.
Hypothesis:
The cerebellar dentate nucleus (CDN), a crucial node for information transmission between the cerebellum and cerebral cortex, shows abnormal functional connectivity with cortex in AD patients. Preclinical studies demonstrated that stimulating lateral cerebellar nucleus, the rodent homologue of the human CDN, enhanced cognitive rehabilitation and improved cortical plasticity in animals after brain injury, suggesting CDN as a neuromodulation target for cognitive networks. We speculate that intermittent θ-burst stimulation (iTBS) based TMS targeting the cerebellar dentate nucleus may improve cognitive function, brain function, and lymphatic drainage in AD patients.
Specific aims:
In this study, we will conduct a randomized, double-blind, sham-controlled clinical trial focusing on the cerebellum with iTBS to assess its efficacy, safety and potential mechanisms in the treatment of AD patients. The findings yielded by the present project will have a potential strong impact on clinical practice of AD patients. Since rTMS is well tolerated and relatively low-priced, a positive result could lead to a fast application of the present proposal to the clinical experience. If successful, the proposed project will provide support for a novel treatment for cognitive dysfunction in AD patients.
- Being tested
- Intermittent Theta-Burst Transcranial Magnetic Stimulation
- Keywords
- Transcranial magnetic stimulation, Intermittent theta burst stimulation, Cerebellar cognitive reserve, Default mode network, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta-Burst Transcranial Magnetic StimulationDevice
50Hz, stimulation intensity of 100% RMT, duration of 40s as a group of stimulation, 600 stimulation pulses, repeated stimulation of bilateral cerebellar dentate nuclei, with a 5-minute interval between each group, 1200 stimulation pulses per site, 5 times a week, treatment for 4 weeks, then treat once a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arms | Active comparator | Participants will receive iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks. Receives: Device: Intermittent Theta-Burst Transcranial Magnetic Stimulation |
| Assigned Interventions | Sham comparator | Participants will receive sham iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks. Receives: Device: Intermittent Theta-Burst Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes）
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, 12 weeks after start of the treatment
Secondary outcomes (5)
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, 12 weeks ,24 weeks and 36 weeks after start of the treatment
The changes in ADCS-ADL（Alzheimer's Disease Cooperative Study - Activities of Daily Living）
ADCS-ADL total score is 54 points, the higher the score，the lighter the symptoms.
Measured: baseline, 12 weeks, 24 weeks and 36 weeks after start of the treatment
The changes in 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, 12 weeks, 24 weeks and 36 weeks after treatment
The changes in MRI（Magnetic Resonance Imaging）
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 12 weeks of TMS treatment, as well as the changes in the cerebellar cortical white matter fiber bundles two month after treatment.
Measured: baseline and 12 weeks after treatment
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes）
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: 24 weeks and 36 weeks after start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start7 Jan 2025
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an No.3 Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669182
- Sponsor's protocol ID
- KY20242285jiangwen
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooperrider J, Furmaga H, Plow E, Park HJ, Chen Z, Kidd G, Baker KB, Gale JT, Machado AG. Chronic deep cerebellar stimulation promotes long-term potentiation, microstructural plasticity, and reorganization of perilesional cortical representation in a rodent model. J Neurosci. 2014 Jul 2;34(27):9040-50. doi: 10.1523/JNEUROSCI.0953-14.2014.
PubMed 24990924Pezzetta R, Gambarota F, Tarantino V, Devita M, Cattaneo Z, Arcara G, Mapelli D, Masina F. A meta-analysis of non-invasive brain stimulation (NIBS) effects on cerebellar-associated cognitive processes. Neurosci Biobehav Rev. 2024 Feb;157:105509. doi: 10.1016/j.neubiorev.2023.105509. Epub 2023 Dec 13.
PubMed 38101590Chan HH, Hogue O, Mathews ND, Hunter JG, Kundalia R, Hermann JK, Floden DP, Machado AG, Baker KB. Deep cerebellar stimulation enhances cognitive recovery after prefrontal traumatic brain injury in rodent. Exp Neurol. 2022 Sep;355:114136. doi: 10.1016/j.expneurol.2022.114136. Epub 2022 Jun 3.
PubMed 35667396Olivito G, Serra L, Marra C, Di Domenico C, Caltagirone C, Toniolo S, Cercignani M, Leggio M, Bozzali M. Cerebellar dentate nucleus functional connectivity with cerebral cortex in Alzheimer's disease and memory: a seed-based approach. Neurobiol Aging. 2020 May;89:32-40. doi: 10.1016/j.neurobiolaging.2019.10.026. Epub 2020 Jan 15.
PubMed 32081466Tacyildiz AE, Bilgin B, Gungor A, Ucer M, Karadag A, Tanriover N. Dentate Nucleus: Connectivity-Based Anatomic Parcellation Based on Superior Cerebellar Peduncle Projections. World Neurosurg. 2021 Aug;152:e408-e428. doi: 10.1016/j.wneu.2021.05.102. Epub 2021 May 29.
PubMed 34062299Benarroch E. What Is the Role of the Dentate Nucleus in Normal and Abnormal Cerebellar Function? Neurology. 2024 Aug 13;103(3):e209636. doi: 10.1212/WNL.0000000000209636. Epub 2024 Jul 2. No abstract available.
PubMed 38954796Di Nuzzo C, Ruggiero F, Cortese F, Cova I, Priori A, Ferrucci R. Non-invasive Cerebellar Stimulation in Cerebellar Disorders. CNS Neurol Disord Drug Targets. 2018;17(3):193-198. doi: 10.2174/1871527317666180404113444.
PubMed 29623859van Dun K, Mitoma H, Manto M. Cerebellar Cortex as a Therapeutic Target for Neurostimulation. Cerebellum. 2018 Dec;17(6):777-787. doi: 10.1007/s12311-018-0976-8.
PubMed 30276522Manto M, Kakei S, Mitoma H. The critical need to develop tools assessing cerebellar reserve for the delivery and assessment of non-invasive cerebellar stimulation. Cerebellum Ataxias. 2021 Jan 4;8(1):2. doi: 10.1186/s40673-020-00126-w.
PubMed 33397496Arleo A, Bares M, Bernard JA, Bogoian HR, Bruchhage MMK, Bryant P, Carlson ES, Chan CCH, Chen LK, Chung CP, Dotson VM, Filip P, Guell X, Habas C, Jacobs HIL, Kakei S, Lee TMC, Leggio M, Misiura M, Mitoma H, Olivito G, Ramanoel S, Rezaee Z, Samstag CL, Schmahmann JD, Sekiyama K, Wong CHY, Yamashita M, Manto M. Consensus Paper: Cerebellum and Ageing. Cerebellum. 2024 Apr;23(2):802-832. doi: 10.1007/s12311-023-01577-7. Epub 2023 Jul 10.
PubMed 37428408Jacobs HIL, Hopkins DA, Mayrhofer HC, Bruner E, van Leeuwen FW, Raaijmakers W, Schmahmann JD. The cerebellum in Alzheimer's disease: evaluating its role in cognitive decline. Brain. 2018 Jan 1;141(1):37-47. doi: 10.1093/brain/awx194.
PubMed 29053771Liang KJ, Carlson ES. Resistance, vulnerability and resilience: A review of the cognitive cerebellum in aging and neurodegenerative diseases. Neurobiol Learn Mem. 2020 Apr;170:106981. doi: 10.1016/j.nlm.2019.01.004. Epub 2019 Jan 7.
PubMed 30630042Thal DR, Rub U, Orantes M, Braak H. Phases of A beta-deposition in the human brain and its relevance for the development of AD. Neurology. 2002 Jun 25;58(12):1791-800. doi: 10.1212/wnl.58.12.1791.
PubMed 12084879Nelson PT, Alafuzoff I, Bigio EH, Bouras C, Braak H, Cairns NJ, Castellani RJ, Crain BJ, Davies P, Del Tredici K, Duyckaerts C, Frosch MP, Haroutunian V, Hof PR, Hulette CM, Hyman BT, Iwatsubo T, Jellinger KA, Jicha GA, Kovari E, Kukull WA, Leverenz JB, Love S, Mackenzie IR, Mann DM, Masliah E, McKee AC, Montine TJ, Morris JC, Schneider JA, Sonnen JA, Thal DR, Trojanowski JQ, Troncoso JC, Wisniewski T, Woltjer RL, Beach TG. Correlation of Alzheimer disease neuropathologic changes with cognitive status: a review of the literature. J Neuropathol Exp Neurol. 2012 May;71(5):362-81. doi: 10.1097/NEN.0b013e31825018f7.
PubMed 22487856Long JM, Holtzman DM. Alzheimer Disease: An Update on Pathobiology and Treatment Strategies. Cell. 2019 Oct 3;179(2):312-339. doi: 10.1016/j.cell.2019.09.001. Epub 2019 Sep 26.
PubMed 31564456
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cerebellar Transcranial Magnetic Stimulation on Patients With Alzheimer's Disease：A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06669182
- Acronym / sponsor ID
- KY20242285jiangwen
- Keywords
- Transcranial magnetic stimulation, Intermittent theta burst stimulation, Cerebellar cognitive reserve, Default mode network, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an No.3 Hospital
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 1 Nov 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.
Alzheimer's Disease (AD) is the primary cause of dementia, with its prominent feature being cognitive decline. The cerebellum plays a crucial role in cognitive processing, making it a potential target for therapeutic intervention. This study will be conducted to evaluate the efficacy and safety of cerebellar Intermittent theta-burst stimulation (CRB-iTBS) in participants with mild Alzheimer's disease on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 3 months of treatment in the Core Study. This project aims to provide a valid treatment to improve the cognitive function and quality of life for those with Alzheimer's disease.
Detailed description
Background:
Alzheimer's disease (AD) is a progressive neurodegenerative disease that poses substantial challenges for both families and society. The primary pathological hallmarks of AD are β-amyloid plaque (Aβ) deposition and neurofibrillary tangles. Notably, the cerebellum seems to be resilient to these pathological developments in the initial phases of AD. This early resistance of the cerebellum suggests it might contribute to compensating for the cognitive impairments associated with AD. Enhancing cerebellar reserve is a potential therapeutic approach. Repetitive transcranial magnetic stimulation (rTMS) has been explored as a means to achieve this, attributed to synaptic plasticity in the cerebellar cortex.
Hypothesis:
The cerebellar dentate nucleus (CDN), a crucial node for information transmission between the cerebellum and cerebral cortex, shows abnormal functional connectivity with cortex in AD patients. Preclinical studies demonstrated that stimulating lateral cerebellar nucleus, the rodent homologue of the human CDN, enhanced cognitive rehabilitation and improved cortical plasticity in animals after brain injury, suggesting CDN as a neuromodulation target for cognitive networks. We speculate that intermittent θ-burst stimulation (iTBS) based TMS targeting the cerebellar dentate nucleus may improve cognitive function, brain function, and lymphatic drainage in AD patients.
Specific aims:
In this study, we will conduct a randomized, double-blind, sham-controlled clinical trial focusing on the cerebellum with iTBS to assess its efficacy, safety and potential mechanisms in the treatment of AD patients. The findings yielded by the present project will have a potential strong impact on clinical practice of AD patients. Since rTMS is well tolerated and relatively low-priced, a positive result could lead to a fast application of the present proposal to the clinical experience. If successful, the proposed project will provide support for a novel treatment for cognitive dysfunction in AD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arms | Active comparator | Device: Intermittent Theta-Burst Transcranial Magnetic StimulationParticipants will receive iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks. |
| Assigned Interventions | Sham comparator | Device: Intermittent Theta-Burst Transcranial Magnetic StimulationParticipants will receive sham iTBS-TMS once a day for 4 weeks, followed by once a week for 8 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 50-85 years old
- Meet the core clinical criteria of NIA-AA for possible Alzheimer's disease dementia, and PET or cerebrospinal fluid markers show elevated p-tau and decreased A β (1-42)
- MMSE score ranges from 18-26 points; CDR score 0.5-1 points
- The patient has received treatment with acetylcholinesterase inhibitors (AChEI), NMDA receptor antagonists, or mannequine therapy, and the current dosing regimen has remained stable for the 12 weeks prior to baseline assessment
- At least one adult caregiver
Key exclusion criteria (12 listed)
- Neurodegenerative disorders other than AD.
- Significant intracranial focal or vascular pathology seen on brain MRI scan
- History of seizure (with the exception of febrile seizures in childhood)
- Any of the following psychotic disorders (DSM IV-TR criteria):
- GDS score ≥ 8 points in baseline assessment
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 |
|---|---|---|
| Intermittent Theta-Burst Transcranial Magnetic Stimulation50Hz, stimulation intensity of 100% RMT, duration of 40s as a group of stimulation, 600 stimulation pulses, repeated stimulation of bilateral cerebellar dentate nuclei, with a 5-minute interval between each group, 1200 stimulation pulses per site, 5 times a week, treatment for 4 weeks, then treat once a week for 8 weeks. | Device | Arms, Assigned Interventions |
Primary outcome
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes）
Time frame: baseline, 12 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
5 secondary outcomes
The changes in MMSE（Mini Mental State Examination）
Time frame: baseline, 12 weeks ,24 weeks and 36 weeks after start of the treatment
The changes in ADCS-ADL（Alzheimer's Disease Cooperative Study - Activities of Daily Living）
Time frame: baseline, 12 weeks, 24 weeks and 36 weeks after start of the treatment
The changes in NPI（Neuropsychiatric Inventory）
Time frame: baseline, 12 weeks, 24 weeks and 36 weeks after treatment
The changes in MRI（Magnetic Resonance Imaging）
Time frame: baseline and 12 weeks after treatment
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes）
Time frame: 24 weeks and 36 weeks after start of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 24990924Cooperrider J, Furmaga H, Plow E, Park HJ, Chen Z, Kidd G, Baker KB, Gale JT, Machado AG. Chronic deep cerebellar stimulation promotes long-term potentiation, microstructural plasticity, and reorganization of perilesional cortical representation in a rodent model. J Neurosci. 2014 Jul 2;34(27):9040-50. doi: 10.1523/JNEUROSCI.0953-14.2014.
- Results publication: PubMed 38101590Pezzetta R, Gambarota F, Tarantino V, Devita M, Cattaneo Z, Arcara G, Mapelli D, Masina F. A meta-analysis of non-invasive brain stimulation (NIBS) effects on cerebellar-associated cognitive processes. Neurosci Biobehav Rev. 2024 Feb;157:105509. doi: 10.1016/j.neubiorev.2023.105509. Epub 2023 Dec 13.
- Results publication: PubMed 35667396Chan HH, Hogue O, Mathews ND, Hunter JG, Kundalia R, Hermann JK, Floden DP, Machado AG, Baker KB. Deep cerebellar stimulation enhances cognitive recovery after prefrontal traumatic brain injury in rodent. Exp Neurol. 2022 Sep;355:114136. doi: 10.1016/j.expneurol.2022.114136. Epub 2022 Jun 3.
- Results publication: PubMed 32081466Olivito G, Serra L, Marra C, Di Domenico C, Caltagirone C, Toniolo S, Cercignani M, Leggio M, Bozzali M. Cerebellar dentate nucleus functional connectivity with cerebral cortex in Alzheimer's disease and memory: a seed-based approach. Neurobiol Aging. 2020 May;89:32-40. doi: 10.1016/j.neurobiolaging.2019.10.026. Epub 2020 Jan 15.
- Results publication: PubMed 34062299Tacyildiz AE, Bilgin B, Gungor A, Ucer M, Karadag A, Tanriover N. Dentate Nucleus: Connectivity-Based Anatomic Parcellation Based on Superior Cerebellar Peduncle Projections. World Neurosurg. 2021 Aug;152:e408-e428. doi: 10.1016/j.wneu.2021.05.102. Epub 2021 May 29.
- Results publication: PubMed 38954796Benarroch E. What Is the Role of the Dentate Nucleus in Normal and Abnormal Cerebellar Function? Neurology. 2024 Aug 13;103(3):e209636. doi: 10.1212/WNL.0000000000209636. Epub 2024 Jul 2. No abstract available.
- Results publication: PubMed 29623859Di Nuzzo C, Ruggiero F, Cortese F, Cova I, Priori A, Ferrucci R. Non-invasive Cerebellar Stimulation in Cerebellar Disorders. CNS Neurol Disord Drug Targets. 2018;17(3):193-198. doi: 10.2174/1871527317666180404113444.
- Results publication: PubMed 30276522van Dun K, Mitoma H, Manto M. Cerebellar Cortex as a Therapeutic Target for Neurostimulation. Cerebellum. 2018 Dec;17(6):777-787. doi: 10.1007/s12311-018-0976-8.
- Results publication: PubMed 33397496Manto M, Kakei S, Mitoma H. The critical need to develop tools assessing cerebellar reserve for the delivery and assessment of non-invasive cerebellar stimulation. Cerebellum Ataxias. 2021 Jan 4;8(1):2. doi: 10.1186/s40673-020-00126-w.
- Results publication: PubMed 37428408Arleo A, Bares M, Bernard JA, Bogoian HR, Bruchhage MMK, Bryant P, Carlson ES, Chan CCH, Chen LK, Chung CP, Dotson VM, Filip P, Guell X, Habas C, Jacobs HIL, Kakei S, Lee TMC, Leggio M, Misiura M, Mitoma H, Olivito G, Ramanoel S, Rezaee Z, Samstag CL, Schmahmann JD, Sekiyama K, Wong CHY, Yamashita M, Manto M. Consensus Paper: Cerebellum and Ageing. Cerebellum. 2024 Apr;23(2):802-832. doi: 10.1007/s12311-023-01577-7. Epub 2023 Jul 10.
- Results publication: PubMed 29053771Jacobs HIL, Hopkins DA, Mayrhofer HC, Bruner E, van Leeuwen FW, Raaijmakers W, Schmahmann JD. The cerebellum in Alzheimer's disease: evaluating its role in cognitive decline. Brain. 2018 Jan 1;141(1):37-47. doi: 10.1093/brain/awx194.
- Results publication: PubMed 30630042Liang KJ, Carlson ES. Resistance, vulnerability and resilience: A review of the cognitive cerebellum in aging and neurodegenerative diseases. Neurobiol Learn Mem. 2020 Apr;170:106981. doi: 10.1016/j.nlm.2019.01.004. Epub 2019 Jan 7.
- Individual participant dataSharing planned: No
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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.
Xijing Hospital of Air Force Military Medical University
Xi'an, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta-Burst Transcranial Magnetic Stimulation in people with Alzheimer Disease and Transcranial Magnetic Stimulation, run by Xijing Hospital at 4 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 6 inclusion and 12 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in CDR-SB（Clinical Dementia Rating-Sum of Boxes） (time frame: baseline, 12 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 NCT06669182, which also lists 20 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 24 Nov 2025.