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

C

Clarity Health Technologies

Status

Enrolling

Conditions

Alzheimer Disease
Healthy Aging

Treatments

Device: Audiovisual stimulation VR system

Study type

Interventional

Funder types

Industry

Identifiers

NCT06234930
AVS_EF_001
SSG0002 (Other Identifier)

Details and patient eligibility

About

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 with mild Alzheimer's disease and age-matched healthy participants.

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, 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 60 participants (n=30 mild AD and n=30 age-matched cognitively normal participants). Audiovisual stimulation will be delivered over two experimental sessions 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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Mild AD Participants:

  • A diagnosis of mild Alzheimer's disease.
  • A 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).
  • Willingness to wear one actigraphy sensor on the dominant wrist during study period.
  • Willingness to do a blood draw.
  • Normal or corrected to normal vision.
  • Normal hearing.
  • Wide Range Achievement Test-4 (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater.
  • Native English speakers or demonstrated fluency in English (participant; and LAR as needed)

Inclusion Criteria Cognitively Normal Participants:

  • Age between 50 - 90 years old.
  • Willingness to sign informed consent document.
  • Willingness to wear one actigraphy sensor on the dominant wrist during study period.
  • Willingness to do a blood draw.
  • Normal or corrected to normal vision.
  • Normal hearing.
  • Wide Range Achievement Test-4 (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater.
  • Native English speakers or demonstrated fluency in English (participant)

Exclusion Criteria Mild AD Participants:

  • Active treatment with a stable dose of acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine), Nmethyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine), or monoclonal antibody medication.
  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • History of narrow angle (acute angle) glaucoma.
  • 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.
  • Impaired visual and/or auditory acuity that is not corrected.
  • 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).

Exclusion Criteria Cognitively Normal Participants:

  • Active treatment with a stable dose of acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine) or Nmethyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine).
  • A history of seizure or epilepsy including family history of seizure or epilepsy.
  • A history of stroke.
  • History of narrow-angle (acute angle) glaucoma.
  • A diagnosis of migraine headache.
  • History of alcohol use disorder within the past 2 years (DSM-V criteria).
  • Impaired visual and/or auditory acuity that is not corrected.
  • 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).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Active and Sham Audiovisual Stimulation (Mild AD):
Experimental group
Description:
Both active and sham stimulation conditions will be delivered to 30 participants with Mild AD to demonstrate the mechanism of action of the intervention.
Treatment:
Device: Audiovisual stimulation VR system
Active and Sham Audiovisual Stimulation (Cognitively Normal):
Experimental group
Description:
Both active and sham stimulation conditions will be delivered to 30 cognitively normal participants to demonstrate the mechanism of action of the intervention.
Treatment:
Device: Audiovisual stimulation VR system

Trial contacts and locations

1

Loading...

Central trial contact

Madisen Wicker, MS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems