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

NCT07596940 | Completed FDA Device

• 2 other identifiers: IRB # 76973 IRB6Internal Funding
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

VR cognitive training platform

EXPERIMENTAL

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

Interventions

VR cognitive training platform DEVICE

See description above.

VR cognitive training platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Markey Cancer Center, Neuro Oncology Outpatient Clinic

Lexington, Kentucky, 40536-0093, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: July 3, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)