A Health Game Intervention for Cancer and Post-ICU Patients Suffering From Acute Cognitive Impairment

A Health Game Intervention for Cancer and Post-ICU Patients Suffering From Acute Cognitive Impairment: A Clinical Study to Assess a New Form of Brain Stimulation Therapy With the Potential to Improve Synaptic Plasticity

Millions of patients each year suffer from acute cognitive impairment caused by traumatic brain injury, stroke, Parkinson's disease, etc. Despite increasing incidences and morbidity, effective pharmacological interventions continue to show a lack of improvement for brain cancer patients. Studies thus far have shown that non-pharmacological interventions have contributed to early success in addressing some forms of cognitive impairment for patients with cognitive dysfunction. We have built a phase-one fully functioning game Hometown Bound that offers cognitive challenges to patients. The aim of this study is to observe for measured improvement of cognitive function among brain cancer patients, which will be validated by the four cognitive scales, measuring efficacy. The first three scales measure patient baseline impairment before and after game play.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: VR cognitive training platform

Detailed Description

After the completion of a usability study, a two-arm, randomized parallel-group efficacy pilot study will be executed with adult brain cancer patients to estimate cognitive improvements using 3 cognitive assessment measures. Arms will include an experimental group (intervention) and the non-gameplay attention group (control).

Experimental group: estimate approximately 10 hours of game play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed

Control group: It is estimated approximately 10 hours of Word-Search and Crossword Puzzle play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed.

Patient total duration of the intervention will be four weeks (3X per week) starting approximately one to two weeks after the conclusion of all cancer treatment (chemo and radiation therapy). Depending on the patients' ability/comfort level, we will determine if they are able to use the VR headset and hand controls.

The 3 cognitive scales:

1. Hopkins Verbal Learning and Memory test
2. Controlled Oral Word Association test (verbal fluency/exec. functions)
3. Trail Making test (processing speed, executive function, visual perception)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • Markey Cancer Center, Neuro Oncology Outpatient Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion criteria of our study are as follows: (1) age 18 years or older, (2) English speaking, (3) Completion of all chemo and radiation therapy and surgical procedures, (4) physical, cognitively, and emotionally able to wear the VR game headset or seat with personal computer flat screen, (5) able to provide consent or through a legally authorized representative, (6) available to play the game three times per week for four consecutive weeks, either in the outpatient clinics or in a location near their home, with the support to provide them transportation to either location and (7) own a cell phone by which they can be reached to make arrangement for testing. Race and gender are not conditions for inclusion in this pilot study.

Exclusion Criteria:

Patients are excluded from our study if any of the following conditions are present: (1) history of mental illnesses and other neurodegenerative diseases such as Alzheimer's disease, vascular dementia, or any other form of advanced neurodegenerative or neuro-cognitive diseases, (2) severe psychiatric illness which is not well controlled, (3) suspected or confirmed drug intoxication/overdose; (5) acute neurologic injury such as traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery, (6) uncorrected hearing or vision impairment including legal blindness, (7) incarcerated at the time of study enrollment, (8) enrolled in another clinical trial which does not permit co-enrollment, or (9) any medical condition precluding safe use of VR headset and hand control technology or physical use of personal computer flat screen and touch pads.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VR cognitive training platform; The virtual reality cognitive training platform is specifically designed for mild cognitive impairment populations. The system, referred to as: Virtual Reality-Cognitive Rehabilitation Training (VR-CRT) offers advantages over traditional computerized cognitive training programs due to its immersive virtual reality environment with 81 embedded attention exercises. VR-CRT is a scenario goal-driven (game) framework that rewards patients with points and feedback at the end of each module to promote engagement and incentivize use. Automated (backend) game score tracking encourages aspirational behavior and goal setting with each module completion. VR-CRT was designed with three interconnecting virtual reality environments/levels, each with their own (progressively demanding) attention exercises, along with the ability for new training module integration, i.e., plug-ins to maintain game novelty and challenge.

Device: VR cognitive training platform; See description above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Verbal Learning and Memory test	The test consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant listens and memorizes the words as the examiner reads the complete word list of 12 items. This is followed by the participant's attempt to recite back the list of words in any order.	4 weeks
Controlled Oral Word Association	This is a verbal fluency test. Participants are instructed to produce as many words as possible in a 1-minute time-period that begin with the letter cues C, F and L, which were originally selected for their increasing difficulty.	4 weeks
Trail Making A-B	This test consists of 25 circles each distributed over a sheet of paper. In Part A, the circles are numbered 1-25 and, in Part B, the circles include both numbers 1-13 and letters A-L. With Part A, the participant is instructed to draw lines to connect the numbers in ascending order and in Part B, the participant is instructed to draw lines to connect the circles in an ascending pattern, while alternating between the numbers and letters (i.e., 1-A, 2-B, 3-C, etc.)	4 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB # 76973 IRB6; Internal Funding (Other Identifier: University of Kentucky CCTS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes