The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation
- Conditions
- Healthy AgingAlzheimer's Disease
- Interventions
- Device: Audiovisual stimulation VR system
- Registration Number
- NCT06234930
- Lead Sponsor
- Clarity Health Technologies, Inc
- Brief 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 cognitively impaired due to Alzheimer's and cognitively unimpaired people.
- Detailed 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 50 participants (n=25 mild AD or MCI due to AD and n=25 cognitively healthy participants). Audiovisual stimulation will be delivered over one experimental session 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active and Sham Audiovisual Stimulation (Cognitively Healthy): Audiovisual stimulation VR system Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention. Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD): Audiovisual stimulation VR system Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.
- Primary Outcome Measures
Name Time Method Incidence of Stimulation-Emergent Adverse Events Immediately after the intervention Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.
Changes in brain activity associated with exposure to VR-based audiovisual stimulation Immediately after the intervention Feasibility of VR-based audiovisual stimulation will be assessed by quantifying significant changes in participants' brainwave activity during varying stimulation frequencies in comparison to baseline.
Level of tolerance to VR-based sensory stimulation exposure Immediately after the intervention Tolerability will be assessed using a Likert scale ranging from 1 (indicating poor) to 7 (indicating good) to evaluate the overall VR-based sensory stimulation experience.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Lakeview Institute of Clinical Research LLC
🇺🇸Leesburg, Florida, United States
The Sequoias Portola Valley
🇺🇸Portola Valley, California, United States