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NCT Number: NCT07313709

Measuring the Feasibility and Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors.

The study is focused on assessing the feasibility and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life.

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Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cognition Disorders Cognitive Dysfunction Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location contact

Anthony Faiola, PhD

PRINCIPAL_INVESTIGATOR

UCCC CTO

CONTACT

[email protected]

513-584-7698

About this study

This study is focused on assessing the feasibility, acceptability and effect of a virtual reality training intervention for improving the survivorship journey of brain cancer survivors, post-treatment. The gaming intervention is intended to reduce cognitive impairment, while increasing well-being, mental health, and quality of life. In sum, the potential impact of this research is to realize the capability of virtual reality cognitive rehabilitation training (VR-CRT) by mitigating brain cancer survivors (BCS) cognitive decline, while improving overall quality of life (QOL).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Low grade glioma survivors.
  • Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25).
  • Completed all cancer treatment for their low-grade glioma (including chemotherapy, immunotherapy, radiation therapy and surgical procedures) and are now >30 days to 24 months from the date of last treatment.
  • Age 18 years or older.
  • English speaking.
  • Able to provide consent without use of a Legally Authorized Representative
  • Available to play the VR game or complete word search puzzles once per day for six days per week for four consecutive weeks in their home (per patient self-report).
  • Have a reliable phone number by which they can be reached to make arrangement for testing and for follow-up calls.

Exclusion criteria

  • 1. History of serious mental or severe psychiatric illnesses (e.g., bi-polar disorder, schizophrenia etc....).

a. Note: Anxiety or depression are not exclusionary. 2. History or known neurodegenerative diseases such as Alzheimer's disease, vascular dementia or any other form of advanced neurodegenerative or neuro-cognitive diseases.

  • History of drug intoxication/overdose (addiction history). 4. History of acute traumatic brain injury. 5. History of stroke causing a cognitive deficit only. 6. Vision impairments including legal blindness.

a. Note: patients with corrected vision (e.g., glasses or contacts) or who are color-blind are eligible.

  • Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of VR headset and hand control technology, including patients with medical devices, including cardiac pacemakers, hearing aids/cochlear implants and defibrillators.
  • History of motion sickness per patient self-report.

Treatment and study plan

virtual reality system

Other

Participants randomized to using VR-CRT will have the game already installed/uploaded in the VR headset and ready for use, with their pre-determined participant number for user login and password assigned.

Word Search Puzzles

Other

Participants randomized to the control group will have their WSP packet with pre-selected word puzzles that provide a cognitive stimulus but without an increase in complexity. The instructions provided will state how participants should complete the WSP day-by-day. The dated completed WSPs, along with weekly check-ins by the study CRC will constitute the record for the participant's progress over four weeks. CRCs will notify the PI via email if during the call the participant indicates they have missed any of the WSPs during a given week.

Primary outcomes

  1. Feasibility defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks.

    Time frame: 4 weeks

    FEASIBILITY: Measure the feasibility of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI).

    Feasibility: will be defined as >80% (> 16 participants out of 20) able to complete the experimental arm study in 4 weeks. Since the standard/control arm is well established and routine, feasibility evaluation is not required in this arm. (If subjects withdraw in disproportion in two arms after the randomization, the study may be suspended for further evaluation.)

  2. Acceptability defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10.

    Time frame: 4 weeks

    ACCEPTABILITY: Measure the acceptability of using VR-CRT and Control (i.e., paper-based Word-search puzzles (WSP)) with brain cancer survivors (BCS) experiencing cancer-related cognitive impairment (CRCI). Acceptability: will be defined as scores of >8 on each subscale of the Senior Technology Acceptance Model (STAM).54 The STAM (Short Version) measures four attitudes towards technology on a Likert scale of 1-10. (See sections 3.1, 17.1 for detail.) This score of >8 for all 14 responses will be calculated as an average of all of the completed sub-scales per each subject. Any missing sub-scales (non-response by subjects) will not be considered into the calculation of the mean per subject. The score of >8 must be observed in >80% (>32 participants) to be considered acceptable.

  3. Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 1.) Hopkins Verbal Learning Test

    Time frame: 4 weeks

    EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by 1.) Hopkins Verbal Learning Test (HVLT)

  4. Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 2.) Controlled Oral Word Association

    Time frame: 4 weeks

    EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 2.) Controlled Oral Word Association (COWA)

  5. Effect of VR-CRT (and Control) on cognitive function measured by scores at baseline and post-intervention,using 3.) Trail Making A-B

    Time frame: 4 weeks

    EFFECT: Estimate the effect of VR-CRT (and Control) on brain cancer survivors' cognitive function such as memory, attention/focus, processing speed, and executive function. Effect: will be measured by comparing scores collected at baseline and post-intervention, (i.e., at the conclusion of a four-week intervention period) using 3.) Trail Making A-B (TMa/b).

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Faiola, PhD

CONTACT

UCCC Clinical Trials Office

CONTACT

[email protected]

513-584-7698

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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