TMS Pilot in Early AD II

NCT ID: NCT06817902

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2026-12-31

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. Transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a case series study to compare sham with iTBS.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent theta burst stimulation

Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the 8Av 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 6-9 weeks.

Group Type: EXPERIMENTAL

Intermittent theta burst stimulation active coil

Intervention Type: DEVICE

MagVenture TMS Therapy active coil 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

Sham device

Subjects will receive treatment with sham coil. There will be a total of 5 treatments over a 2-week period. Coil will be placed over the same region as the experimental group. Total participation will be 6-9 weeks. An open-label extension will be offered to participants that received the sham (control) treatment without further data collection.

Group Type: SHAM_COMPARATOR

Sham coil

Intervention Type: DEVICE

MagVenture TMS Therapy sham coil

Interventions

Intermittent theta burst stimulation active coil

MagVenture TMS Therapy active coil 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

Intervention Type: DEVICE

Sham coil

MagVenture TMS Therapy sham coil

Intervention Type: DEVICE

Other Intervention Names

Transmagnetic stimulation; MagVenture; MagVenture

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 Status Examination (MMSE) >24
• Clinical Dementia Rating (CDR) 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 resting state-function magnetic resonance imaging (rs-fMRI)
• Contraindication of rs-fMRI due to implants or metal
• Seizure disorder

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhavani Kashyap, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A21-251-01

Identifier Type: -

Identifier Source: org_study_id