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

Alzheimer Disease Clinical Trial

— CAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234930
• Other study ID #: AVS_EF_001
• Secondary ID: SSG0002
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: January 2024
• Source: Clarity Health Technologies, Inc
• Contact: Madisen Wicker, MS
• Phone: 484-484-4268
• Email: madisenwicker[@]symmetryscienceconsulting.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Healthy Aging

Intervention

Device:
• Audiovisual stimulation VR system
Delivery of synchronized auditory and visual stimuli at varying frequencies via a VR headset.

Locations

Country	Name	City	State
United States	Urban Co-Works	Scranton	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Clarity Health Technologies, Inc	SymmetryScience Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of Stimulation-Emergent Adverse Events	Safety will be assessed via a questionnaire asking for any stimulation-related adverse effects.	Immediately after the intervention