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

NCT ID: NCT06234930

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2025-03-14

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.

Conditions

Healthy Aging; Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Audiovisual stimulation VR system

Intervention Type: DEVICE

Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.

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.

Group Type: EXPERIMENTAL

Audiovisual stimulation VR system

Intervention Type: DEVICE

Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.

Interventions

Audiovisual stimulation VR system

Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.

Intervention Type: DEVICE

Other Intervention Names

VR-based audiovisual stimulation; Sensory stimulation

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clarity Health Technologies, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolina Reis, PhD

Role: PRINCIPAL_INVESTIGATOR

Clarity Health Technologies

Locations

The Sequoias Portola Valley

Portola Valley, California, United States

Lakeview Institute of Clinical Research LLC

Leesburg, Florida, United States

Countries

United States

Other Identifiers

CHT0001

Identifier Type: -

Identifier Source: org_study_id