Healthy AgingCFSNCT06234930
The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation
A study testing Audiovisual stimulation VR system in people with Healthy Aging and Alzheimer's Disease, run by Clarity Health Technologies, Inc at 2 sites in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Audiovisual stimulation VR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2024to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lakeview Institute of Clinical Research LLC
Leesburg, Florida, 34748
The Sequoias Portola Valley
Portola Valley, California, 94028
About this study
Official title: The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation
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.
Read the 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, 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.
- Being tested
- Audiovisual stimulation VR system
- Keywords
- Sensory neurostimulation, Non-invasive neuromodulation, Alzheimer's Disease, AD, Healthy, 50-90 years old, Gamma sensory stimulation, Virtual Reality, MCI
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual stimulation VR systemDevice
Also called VR-based audiovisual stimulation, Sensory stimulation
Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2: MCI due to AD or Mild AD | Experimental | 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. Receives: Device: Audiovisual stimulation VR system |
| Cohort 1: Cognitively Unimpaired Older Adults | Experimental | 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. Receives: Device: Audiovisual stimulation VR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention
Incidence of Stimulation-Emergent Adverse Events
Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start11 Jul 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two non-randomized cohorts, enrolled sequentially at two sites: cognitively unimpaired older adults (Cohort 1) and participants with MCI due to Alzheimer's disease or mild Alzheimer's disease (Cohort 2). Within a single session, every participant received both active 40 Hz audiovisual stimulation and a sham condition (within-subject comparison).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarity Health Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolina Reis, PhD, Principal investigator, Clarity Health Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234930
- Sponsor's protocol ID
- CHT0001
- Acronym
- CFS
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data publicly available. De-identified data supporting the published results may be made available by the sponsor upon reasonable request, subject to a data use agreement and applicable consent and privacy restrictions.
Publications
Reis C, Hainke L, Headley G, Navarro S, Zanto TP, Certain R. Feasibility of immersive 40 Hz gamma sensory stimulation in early-stage Alzheimer's disease. J Prev Alzheimers Dis. 2026 Sep 25;13(10):100679. doi: 10.1016/j.tjpad.2026.100679. Online ahead of print.
PubMed 42790402Reis C, Azizollahi H, Headley G, Navarro S, Hanslmayr S, Clouter A, Zanto TP, Certain R. VR-based gamma sensory stimulation: a pilot feasibility study. Sci Rep. 2025 Aug 5;15(1):28491. doi: 10.1038/s41598-025-13725-6.
PubMed 40764732
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation
- ClinicalTrials.gov ID
- NCT06234930
- Acronym / sponsor ID
- CFS / CHT0001
- Keywords
- Sensory neurostimulation, Non-invasive neuromodulation, Alzheimer's Disease, AD, Healthy, 50-90 years old, Gamma sensory stimulation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Clarity Health Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two non-randomized cohorts, enrolled sequentially at two sites: cognitively unimpaired older adults (Cohort 1) and participants with MCI due to Alzheimer's disease or mild Alzheimer's disease (Cohort 2). Within a single session, every participant received both active 40 Hz audiovisual stimulation and a sham condition (within-subject comparison).
| Arm | Type | Receives |
|---|---|---|
| Cohort 2: MCI due to AD or Mild AD | Experimental | Device: Audiovisual stimulation VR systemParticipants 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. |
| Cohort 1: Cognitively Unimpaired Older Adults | Experimental | Device: Audiovisual stimulation VR systemCognitively 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual stimulation VR systemAlso: VR-based audiovisual stimulation, Sensory stimulationDelivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset. | Device | Cohort 1: Cognitively Unimpaired Older Adults, Cohort 2: MCI due to AD or Mild AD |
Primary outcome
Changes in brain activity associated with exposure to VR-based audiovisual stimulation
Time frame: Immediately after the intervention
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.
Level of tolerance to VR-based sensory stimulation exposure
Time frame: Immediately after the intervention
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.
Incidence of Stimulation-Emergent Adverse Events
Time frame: Immediately after the intervention
Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 42790402Reis C, Hainke L, Headley G, Navarro S, Zanto TP, Certain R. Feasibility of immersive 40 Hz gamma sensory stimulation in early-stage Alzheimer's disease. J Prev Alzheimers Dis. 2026 Sep 25;13(10):100679. doi: 10.1016/j.tjpad.2026.100679. Online ahead of print.
- Results publication: PubMed 40764732Reis C, Azizollahi H, Headley G, Navarro S, Hanslmayr S, Clouter A, Zanto TP, Certain R. VR-based gamma sensory stimulation: a pilot feasibility study. Sci Rep. 2025 Aug 5;15(1):28491. doi: 10.1038/s41598-025-13725-6.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data publicly available. De-identified data supporting the published results may be made available by the sponsor upon reasonable request, subject to a data use agreement and applicable consent and privacy restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Reis, PhD principal investigator
Clarity Health Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual stimulation VR system in people with Healthy Aging and Alzheimer's Disease, run by Clarity Health Technologies, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain activity associated with exposure to VR-based audiovisual stimulation (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06234930, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.