Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease

H

HealthPartners Institute

Status

Completed

Conditions

Alzheimer Disease

Treatments

Device: Intermittent theta burst stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05292222
A21-251

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Intermittent theta burst stimulation
Experimental group
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.
Treatment:
Device: Intermittent theta burst stimulation

Trial contacts and locations

0

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Central trial contact

Research Coordinator

Data sourced from clinicaltrials.gov

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