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

NCT06234930 | Completed

• 1 other identifier: CHT0001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Aging; Alzheimer's Disease

Keywords

Sensory neurostimulation; Non-invasive neuromodulation; Alzheimer's Disease; AD; Healthy; 50-90 years old; Gamma sensory stimulation; Virtual Reality; MCI

Outcome Measures

Primary Outcomes (3)

• Changes in brain activity associated with exposure to VR-based audiovisual stimulation

  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.

  Immediately after the intervention

• Level of tolerance to VR-based sensory stimulation exposure

  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.

  Immediately after the intervention

• Incidence of Stimulation-Emergent Adverse Events

  Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.

  Immediately after the intervention

Study Arms (2)

Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):

EXPERIMENTAL

Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.

Device: Audiovisual stimulation VR system

Active and Sham Audiovisual Stimulation (Cognitively Healthy):

EXPERIMENTAL

Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.

Device: Audiovisual stimulation VR system

Interventions

Audiovisual stimulation VR system DEVICE

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

Also known as: VR-based audiovisual stimulation, Sensory stimulation

Active and Sham Audiovisual Stimulation (Cognitively Healthy):; Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarity Health Technologies, Inc: lead

Study Sites (2)

The Sequoias Portola Valley

Portola Valley, California, 18503, United States

Location

Lakeview Institute of Clinical Research LLC

Leesburg, Florida, 34748, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carolina Reis, PhD

  Clarity Health Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will undergo sequential exposure to various stimulation conditions in a random order. The nature of each condition will not be disclosed to participants. The experimenter is unmasked to ensure protocol adherence.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham-controlled study where participants from two groups (Cognitively Impaired due to AD and Cognitively Healthy participants) are exposed to both active and sham conditions.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 31, 2024
• Study Start: July 11, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)