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NCT06234930Completed

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

The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
27 (actual)
First submitted
12 Jan 2024
Start date
11 Jul 2024
Primary completion date
14 Mar 2025
Lead sponsor
Clarity Health Technologies, Inc
NCT number
NCT06234930

What you commit to

  • Study type: Interventional
  • Participants enrolled: 27
  • From 11 Jul 2024 to the primary completion date, 14 Mar 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • History of alcohol use disorder within the past 2 years (DSM-V criteria).
  • Current or past history of any neurological disorder other than dementia.
  • 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.
  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • History of alcohol use disorder within the past 2 years (DSM-V criteria).
  • 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.

Other

  • A diagnosis of migraine headache.
  • Use of hearing aid device(s).
  • Pregnancy (Verbal confirmation).
  • Geriatric Depression Scale (GDS) \>8
  • A diagnosis of migraine headache.
  • Use of hearing aid device(s).
  • Pregnancy (Verbal confirmation)
  • Geriatric Depression Scale (GDS) \>8

Who the study is looking for

  • 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)

Age in the registry: 50 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Lakeview Institute of Clinical Research LLC
Coordinator of this site? Confirm its status
LeesburgUnited StatesUnknown status
The Sequoias Portola Valley
Coordinator of this site? Confirm its status
Portola ValleyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.