The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation (CFS)

Clarity Health Technologies

Status: Completed

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Healthy Aging

Treatments: Device: Audiovisual stimulation VR system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06234930

CHT0001

Details and patient eligibility

About

This single-session, within-subject, sham-controlled early feasibility study evaluated the safety, tolerability, and feasibility of delivering 40 Hz audiovisual (gamma sensory) stimulation through a virtual reality (VR) headset in cognitively unimpaired older adults and in people with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease.

Full 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, this study explored the feasibility, safety, and tolerability of delivering acute audiovisual stimulation via a Virtual Reality (VR) headset.

The study enrolled two non-randomized cohorts at two U.S. sites: 16 cognitively unimpaired older adults (The Sequoias Portola Valley, California) and 11 participants with MCI due to AD or mild AD (Lakeview Institute of Clinical Research, Florida; site added with IRB approval). Enrollment closed at 27 of the 50 participants originally planned (25 per cohort). Each participant completed one experimental session in which audiovisual stimulation was delivered within VR environments; all participants were exposed to active 40 Hz stimulation and to a sham condition. Electroencephalography (EEG) was recorded to measure the responsiveness of participants' brain activity to the acute intervention, and safety and tolerability were assessed with questionnaires. The VR environments and the associative-memory task were adapted for the second cohort; the procedures used in each cohort are described in the corresponding publications (see References).

This study was designed to inform the development of a non-invasive therapy for early-stage Alzheimer's disease by assessing the feasibility and safety of using VR technology to deliver audiovisual stimulation.

Enrollment: 27 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Cohort 2: MCI due to AD or Mild AD

Experimental group

Description:

Participants with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease (n=11 enrolled; Lakeview Institute of Clinical Research, Leesburg, FL). In a single session, each participant received active 40 Hz audiovisual stimulation and sham stimulation delivered via a VR headset, with concurrent EEG.

Treatment:

Device: Audiovisual stimulation VR system

Cohort 1: Cognitively Unimpaired Older Adults

Experimental group

Description:

Cognitively unimpaired older adults (MoCA \>= 26; n=16 enrolled; The Sequoias Portola Valley, CA). In a single session, each participant received active 40 Hz audiovisual stimulation and sham stimulation delivered via a VR headset, with concurrent EEG.

Treatment:

Device: Audiovisual stimulation VR system