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

NCT ID: NCT07313709

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-05-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Brain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After eligibility is confirmed, participants will be randomized into either the Experimental (Virtual Reality) or Control (Word Search Puzzles) Arms. Participants will be randomized in blocks of 4 through a computer-generated randomization such that the final n in the experimental arm is 20 and the control arm is 20. If a participant has to drop out of the study for any reason after randomization and start of the baseline/onboarding phase (e.g., due to motion sickness during participation) this will be considered in the assessment of feasibility for this study and they will not be replaced. The UCCC Data Manager will issue subject randomization to the study team upon receipt of confirmation of eligibility (with eligibility being confirmed per UCCC CTO workflows).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental (Virtual Reality - VR)

Experimental (VR) Participants ONLY:

Participants randomized to using Virtual Reality-Cognitive Rehab Training (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.

Group Type EXPERIMENTAL

Virtual Reality System

Intervention Type 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.

Control (WSP)

Control (WSP) Participants ONLY:

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.

Group Type ACTIVE_COMPARATOR

Word Search Puzzles

Intervention Type 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.

Interventions

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Virtual Reality System

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.

Intervention Type OTHER

Word Search Puzzles

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Low grade glioma survivors.
2. Have mild cognitive impairment (MCI) per MoCA (defined as any score between 18 and 25).
3. 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.
4. Age 18 years or older.
5. English speaking.
6. Able to provide consent without use of a Legally Authorized Representative
7. 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).
8. 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.

3\. 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.

7\. 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.

10\. History of motion sickness per patient self-report.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Anthony Faiola

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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UCCC Clinical Trials Office

Role: CONTACT

513-584-7698

Anthony Faiola, PhD

Role: CONTACT

Facility Contacts

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UCCC CTO

Role: primary

513-584-7698

Other Identifiers

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UCCC-BN-25-01

Identifier Type: -

Identifier Source: org_study_id

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