Clincosm LogoSign in Get a demo

Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease

Sponsor
HealthPartners Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05292222
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
7.5
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intermittent theta burst stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 17, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intermittent theta burst stimulation

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.

Device: Intermittent theta burst stimulation
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
Other Names:
  • Transmagnetic stimulation
  • MagVenture

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in connectivity measure of the TGd parcellations. [9 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HealthPartners Neuroscience Center Saint Paul Minnesota United States 55130

    Sponsors and Collaborators

    • HealthPartners Institute

    Investigators

    • Principal Investigator: Michael H Rosenbloom, MD, HealthPartners Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HealthPartners Institute
    ClinicalTrials.gov Identifier:
    NCT05292222
    Other Study ID Numbers:
    • A21-251
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by HealthPartners Institute
    transmagnetic stimulation
    functional MRI guided Theta Burst Stimulation
    Early Stage
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Aug 23, 2022