Back to resultsTransmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent theta burst stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring transmagnetic stimulation, functional MRI guided Theta Burst Stimulation, Early Stage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
- Inability to tolerate rs-fMRI
- Contraindication of rs-fMRI due to implants or metal
- Seizure disorder
Sites / Locations
- HealthPartners Neuroscience Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intermittent theta burst stimulation
Arm Description
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Outcomes
Primary Outcome Measures
Change in connectivity measure of the TGd parcellations.
Assessed by calculating the difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1.
Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
Secondary Outcome Measures
Full Information
NCT ID
NCT05292222
First Posted
March 14, 2022
Last Updated
October 2, 2023
Sponsor
HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT05292222
Brief Title
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
transmagnetic stimulation, functional MRI guided Theta Burst Stimulation, Early Stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent theta burst stimulation
Arm Type
Experimental
Arm Description
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
Intervention Type
Device
Intervention Name(s)
Intermittent theta burst stimulation
Other Intervention Name(s)
Transmagnetic stimulation, MagVenture
Intervention Description
MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
Primary Outcome Measure Information:
Title
Change in connectivity measure of the TGd parcellations.
Description
Assessed by calculating the difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1.
Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
Inability to tolerate rs-fMRI
Contraindication of rs-fMRI due to implants or metal
Seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Rosenbloom, MD
Organizational Affiliation
HealthPartners Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No identifiable data will be shared with other researchers.
Learn more about this trial
Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
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