NCT05947045

Brief Summary

The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:

  1. 1.Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects?
  2. 2.Will cognitive training via virtual reality provide neurocognitive benefits?
  3. 3.Will there be predictable changes in brain activity as measured by neuroimaging?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jun 2023Mar 2027

First Submitted

Initial submission to the registry

June 7, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

June 7, 2023

Last Update Submit

April 21, 2026

Conditions

Brain Tumor

Keywords

RadiotherapyBrain tumorCognitive trainingVirtual RealityWorking memory

Outcome Measures

Primary Outcomes (3)

  • Participation Rate

    The participation rate of this study (i.e., how many patients agree to participate/how many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants.

    After approach for enrollment, an average of 3 weeks after starting radiation therapy

  • Adherence

    The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups.

    At the completion of radiation therapy, an average of 6 weeks after enrollment

  • Side Effects

    Summary statistics, including counts and percentages of side effects/cyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality.

    At the completion of radiation therapy, an average of 6 weeks after enrollment

Secondary Outcomes (2)

  • Neurobehavioral

    After completion of post-training assessment, an average of 8 weeks after enrollment

  • Cerebral Hemodynamics

    After completion of post-training assessment, an average of 8 weeks after enrollment

Study Arms (2)

IPad Cogmed Training

ACTIVE COMPARATOR

The investigator will be randomizing participants to complete Cogmed training on an iPad.

Other: Cognitive training via iPad

Virtual Reality Cogmed Training

EXPERIMENTAL

The investigator will be randomizing participants to complete Cogmed training in Virtual Reality.

Other: Cognitive training via virtual reality

Interventions

Cognitive training via iPadOTHER

Participants will complete five sessions of the Cogmed training program on an iPad. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.

IPad Cogmed Training
Cognitive training via virtual realityOTHER

Participants will complete five sessions of the Cogmed training program within virtual reality. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.

Virtual Reality Cogmed Training

Eligibility Criteria

Age8 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Initiating radiotherapy for a BT
  • Between 8-22 years of age at the time of enrollment
  • English or Spanish as the primary language
  • Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
  • Participant willing to take part in required aspects of Cogmed training

You may not qualify if:

  • Significant impairment in global intellectual functioning (estimated or full scale IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \[NOPP\])
  • History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness
  • Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)
  • Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)
  • Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation/planning but not daily treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Andrew Heitzer, PhD, ABPP-CN

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

  • Heather Conklin, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Conklin, PhD

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single Blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

July 14, 2023

Study Start

June 22, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(1)