NCT06817902

TMS Pilot in Early AD II

A Preliminary Sham-Controlled Theta Burst Stimulation (TBS) Study in Early-Stage Alzheimer's Disease (AD)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
DEVICE	Sham coil	MagVenture TMS Therapy sham coil

Timeline

• Start date: 2024-12-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-10
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study