TBI (Traumatic Brain Injury)NCT03605017
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
A study testing Virtual Reality Executive Function Training (VREFT) in people with TBI (Traumatic Brain Injury), run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Virtual Reality Executive Function Training (VREFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2014to 26 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18-65
- diagnosis of TBI
- can read and speak English fluently
Who cannot join
- prior stroke or neurological disease other than TBI
- unstable or uncontrolled seizures
- currently taking benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Denise Krch, PhD, 973-324-8392, dkrch@kesslerfoundation.org
Angela Smith, BA, 9733248448, asmith@kesslerfoundation.org
About this study
The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). The study is designed to evaluate how well this technique can help people with TBI increase their attention and ability to function better in everyday life.
Read the detailed description
A pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with TBI will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Participants are random assigned to either the experimental or control groups. Experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Virtual Reality Executive Function Training (VREFT)
- Keywords
- cognitive rehabilitation, attention, executive function
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Executive Function Training (VREFT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| VREFT: Wonderkin Treatment | Experimental | Administered by computer Receives: Behavioral: Virtual Reality Executive Function Training (VREFT) |
| VREFT: Attention Control | Active comparator | Administered by computer Receives: Behavioral: Virtual Reality Executive Function Training (VREFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total divided attention post-treatment (covarying for baseline performance)
Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams
Measured: 7 weeks (between pre- and post-testing)
Total set-shifting post-treatment (covarying for baseline performance)
Comparison between treatment and control groups on post-treatment Stroop interference
Measured: 7 weeks (between pre- and post-testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start26 Mar 2014
- Primary completion26 Mar 2022 (estimated)
- Study completion26 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Denise Krch, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605017
- Sponsor's protocol ID
- R-820-14
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2018
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI
- ClinicalTrials.gov ID
- NCT03605017
- Acronym / sponsor ID
- R-820-14
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- cognitive rehabilitation, attention, executive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 26 Mar 2022 (estimated)
- Study completion
- 26 Mar 2022 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). The study is designed to evaluate how well this technique can help people with TBI increase their attention and ability to function better in everyday life.
Detailed description
A pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with TBI will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Participants are random assigned to either the experimental or control groups. Experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VREFT: Wonderkin Treatment | Experimental | Behavioral: Virtual Reality Executive Function Training (VREFT)Administered by computer |
| VREFT: Attention Control | Active comparator | Behavioral: Virtual Reality Executive Function Training (VREFT)Administered by computer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between the ages of 18-65
- diagnosis of TBI
- can read and speak English fluently
Key exclusion criteria (3 listed)
- prior stroke or neurological disease other than TBI
- unstable or uncontrolled seizures
- currently taking benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Executive Function Training (VREFT) | Behavioural | VREFT: Attention Control, VREFT: Wonderkin Treatment |
Primary outcome
Total divided attention post-treatment (covarying for baseline performance)
Time frame: 7 weeks (between pre- and post-testing)
Comparison between treatment and control groups on post-treatment Auditory Consonant Trigrams
Total set-shifting post-treatment (covarying for baseline performance)
Time frame: 7 weeks (between pre- and post-testing)
Comparison between treatment and control groups on post-treatment Stroop interference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Executive Function Training (VREFT) in people with TBI (Traumatic Brain Injury), run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Krch, PhD (973-324-8392, dkrch@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total divided attention post-treatment (covarying for baseline performance) (time frame: 7 weeks (between pre- and post-testing)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.