Brain Health Virtual Reality Study

Aging Clinical Trial

Official title:

Interventions to Promote Brain Health Virtual Reality Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124339
• Other study ID #: 803273
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: February 1, 2029

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Study Coordinator
• Phone: 6195432113
• Email: Brainhealth[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2029
• Est. primary completion date: August 8, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 50-85 years of age

2. Fluent in English

3. Can safely ride a stationary bike

Exclusion Criteria:

1. Dementia

2. History of a neurological disorder

3. Severe sensory deficits

4. Inability to perform intervention (e.g., inability to cycle safely)

5. Contraindications to MRI scan (e.g., pacemaker)

6. Fear of needles/ blood

7. Prior history of fainting due to sight of needles of blood

Related Conditions & MeSH terms

• Aging
• Aging Problems
• Cognition Disorders
• Cognition Disorders in Old Age
• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Memory Disorders
• Memory Disorders in Old Age
• Memory Impairment
• Memory Loss
• Mild Cognitive Impairment

Intervention

Behavioral:
• Physical Activity
There will be three sessions a week over the course of 16 weeks.
• Cognitive Activity (VR)
There will be three sessions a week over the course of 16 weeks.
• Physical and Cognitive Activity
There will be three sessions a week over the course of 16 weeks.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal MRI	The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a dysfunctional brain signal in the hippocampus in MCI patients. We propose to examine the effects of exercise on remediating this hyperactive signal exhibited in MCI patients.	16 Weeks
Primary	MST memory performance	With the study's primary focus on hippocampal function, we will use the Mnemonic Separation Task (MST), a hippocampus-dependent discrimination test of similar objects, as our primary cognitive outcome. The MST is a memory task designed to heavily tax memory processes for making fine discriminations between highly similar objects or unrelated objects.	16 Weeks