NCT06135051

Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.

Conditions

• Alzheimer Disease
• Dementia
• Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	Diadem prototype	The device delivers low-intensity ultrasonic waves into specific brain targets.

Timeline

• Start date: 2024-08-18
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2023-11-18
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States