NCT05292222Completed
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Early-Stage Alzheimer's Disease (AD)
Source: ClinicalTrials.gov · Last updated 7 Jan 2025
Brief summary (registry, in English)
Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 17 Jun 2022
- Primary completion date
- 7 Nov 2023
- Lead sponsor
- HealthPartners Institute
- Diseases
- Alzheimer disease
- NCT number
- NCT05292222
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 17 Jun 2022 to the primary completion date, 7 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication of rs-fMRI due to implants or metal
Other illness
- Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
- Seizure disorder
Other
- Inability to tolerate rs-fMRI
Who the study is looking for
- Established diagnosis of Mild Cognitive Impairment (MCI)/mild AD
- Evidence for Central Nervous System (CNS) amyloidosis (e.g., Amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) biomarkers consistent with AD)
- Prior brain imaging performed
- Mini-Mental State Examination (MMSE) \>24
- Clinical Dementia Rating (CDR) Scale 0.5-1
- Stable dose of cholinesterase inhibitors and memantine for at least one month
- Subjects are between 40-90 years of age
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HealthPartners Neuroscience Center Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.