The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation (CFS)
The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Portola Valley, California, United States, 18503
- The Sequoias Portola Valley
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Florida
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Leesburg, Florida, United States, 34748
- Lakeview Institute of Clinical Research LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Mild AD/ MCI due to AD Participants:
- Age between 50 - 90 years old.
- A clinical diagnosis of Mild Cognitive Impairment due to Alzheimer's disease (confirmed by PET scan or CSF biomarkers) or Mild Alzheimer's disease
- MoCA score of 18-25.
- Willingness to sign informed consent document (if deemed to not have the capacity to sign the informed consent, a legally authorized representative will be asked to provide surrogate consent).
- Sufficient visual and hearing ability.
- Formal education of 8 or more years.
- Native English speakers or demonstrated fluency in English (participant; and LAR as needed)
Inclusion Criteria Cognitively Healthy Participants:
- Age between 50 - 90 years old.
- A MoCA score above or equal to 26.
- Willingness to sign informed consent document.
- Sufficient visual and hearing ability.
- Formal education of 8 or more years.
- Native English speakers or demonstrated fluency in English (participant)
Exclusion Criteria Mild AD/ MCI due to AD Participants:
- Previous exposure to monoclonal antibody medication (e.g., Lecanemab, Aducanumab).
- Active treatment with Memantine within the past 30 days.
- Initiation of acetylcholinesterase inhibitors within the past 30 days.
- A history of seizure or epilepsy including family history of seizure or epilepsy.
- A history of stroke.
- A diagnosis of migraine headache.
- History of alcohol use disorder within the past 2 years (DSM-V criteria).
- Current or past history of any neurological disorder other than dementia.
- Use of hearing aid device(s).
- Any known blood pathogens or disorders.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
- Pregnancy (Verbal confirmation).
- Geriatric Depression Scale (GDS) >8
Exclusion Criteria Cognitively Healthy Participants:
- Active treatment with Memantine within the past 30 days.
- Initiation of treatment with acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine) within the past 30 days.
- A history of seizure or epilepsy including family history of seizure or epilepsy.
- A history of stroke.
- A diagnosis of migraine headache.
- History of alcohol use disorder within the past 2 years (DSM-V criteria).
- Use of hearing aid device(s).
- Any known blood pathogens or disorders.
- A diagnosis of Alzheimer's disease and related dementias.
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
- Pregnancy (Verbal confirmation)
- Geriatric Depression Scale (GDS) >8
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):
Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.
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Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.
Other Names:
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Experimental: Active and Sham Audiovisual Stimulation (Cognitively Healthy):
Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.
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Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in brain activity associated with exposure to VR-based audiovisual stimulation
Time Frame: Immediately after the intervention
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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.
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Immediately after the intervention
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Level of tolerance to VR-based sensory stimulation exposure
Time Frame: Immediately after the intervention
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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.
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Immediately after the intervention
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Incidence of Stimulation-Emergent Adverse Events
Time Frame: Immediately after the intervention
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Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.
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Immediately after the intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolina Reis, PhD, Clarity Health Technologies
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHT0001
- SSG0002 (Other Identifier: SymmetryScience Group, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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