Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06234930
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-12
Brief Title:
The Feasibility Safety and Tolerability of VR-based Audiovisual Stimulation
Sponsor:
Clarity Health Technologies Inc
Organization:
Clarity Health Technologies Inc
Study Overview
Official Title:
The Feasibility Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CFS
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 Alzheimers 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 Alzheimers 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 n25 mild AD or MCI due to AD and n25 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 Alzheimers disease while assessing the feasibility and safety of using VR technology to deliver audiovisual stimulation
Recent literature suggests that when applied chronically audiovisual stimulation may slow down the progression of Alzheimers 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 n25 mild AD or MCI due to AD and n25 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 Alzheimers disease while assessing the feasibility and safety of using VR technology to deliver audiovisual stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SSG0002 | OTHER | SymmetryScience Group Inc | None |