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Clinical Trial Summary

This is a single-blind, sham-controlled, clinical trial that aims to evaluate the safety, tolerability, and feasibility of delivering audiovisual stimulation via a Virtual Reality (VR) headset to people with mild Alzheimer's disease and age-matched healthy participants.


Clinical Trial Description

Audiovisual stimulation is a non-invasive approach that uses synchronized light and sound stimuli to modulate neural activity and cognitive processes. Recent literature suggests that when applied chronically, audiovisual stimulation may slow down the progression of Alzheimer's disease (AD). In contrast to traditional methods employing Light Emitting Diodes (LEDs) and computer screens for the delivery of visual stimuli, our study explores the feasibility, safety, and tolerability of delivering acute audiovisual stimulation via a Virtual Reality (VR) headset. The investigators plan to recruit a total of 60 participants (n=30 mild AD and n=30 age-matched cognitively normal participants). Audiovisual stimulation will be delivered over two experimental sessions to every participant. Stimuli will be embedded in passive environments and in a sound-video associative memory task. All participants will be exposed to stimulation at different frequencies and a sham condition will be used as a control. To determine the feasibility of VR-based audiovisual stimulation, the investigators will use electroencephalography (EEG) and measure the responsiveness of participants' brain activity to the acute intervention. Safety and tolerability will be evaluated using questionnaires. This clinical trial aims to provide valuable insights into the development of a non-invasive therapy for early-stage Alzheimer's disease, while assessing the feasibility and safety of using VR technology to deliver audiovisual stimulation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06234930
Study type Interventional
Source Clarity Health Technologies, Inc
Contact Madisen Wicker, MS
Phone 484-484-4268
Email madisenwicker@symmetryscienceconsulting.com
Status Recruiting
Phase N/A
Start date December 14, 2023
Completion date April 15, 2024

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