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NCT Number: NCT07596940

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Markey Cancer Center, Neuro Oncology Outpatient Clinic

Lexington, Kentucky, 40536-0093, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR cognitive training platform

Device

See description above.

Primary outcomes

  1. Hopkins Verbal Learning and Memory test

    Time frame: 4 weeks

    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.

  2. Controlled Oral Word Association

    Time frame: 4 weeks

    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.

  3. Trail Making A-B

    Time frame: 4 weeks

    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.)

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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