Acquired Brain InjuryNCT04017091
Neurocognitive Rehabilitation Using Virtual Reality
A study testing Virtual Reality Cognitive Training in people with Acquired Brain Injury, run by Baylor Research Institute.
Trial summary
Objective: To determine whether immersive virtual reality (VR) treatment interventions improve executive dysfunction and complex attention deficits in patients with brain injury compared with standard neurorehabilitation, and whether VR performance predicts neurorehabilitation outcomes at discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Virtual Reality Cognitive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 30 May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older
- Diagnosis of acquired traumatic or non-traumatic neurologic illness
- Documented dysfunction in executive and attention skills
- OLOG/Cog-Log score ≥ 25/30
Who cannot join
- Medically unstable (as deemed by primary doctor)
- Aphasic
- Hemispatial neglect
- Prior history of significant neurological complications
- Prior history of developmental delay resulting in compromised cognition
- Prisoners
- Non-English speaking
About this study
Official title: The Impact of Virtual Reality Training on Executive and Complex Attentional Functions and Association With Neurorehabilitation Outcomes
Objective: To determine whether immersive virtual reality (VR) treatment interventions improve executive dysfunction and complex attention deficits in patients with brain injury compared with standard neurorehabilitation, and whether VR performance predicts neurorehabilitation outcomes at discharge.
Design: Mixed design study with quasi-experimental Intervention group (N = 12) and retrospective Control group (N = 12). Both groups were compromised of individuals with brain injury admitted to an outpatient day neurorehabilitation program.
Read the detailed description
The current study focuses on repeated practice of a VR-based cognitive intervention with the intent of improving cognitive deficits known to impact ability to resume complex activities. This study details implementation of VR within a neurorehabilitation setting. Associations between the VR Stroop and neuropsychological, speech therapy, and global rehabilitation measures are examined. The investigators include a brain injured control group to address this frequently cited methodological concern.
Inclusion Criteria Patients participating in this study were aged 18 years and older diagnosed with acquired traumatic or non-traumatic neurologic illness, and with dysfunction in executive and attention skills documented during their inpatient rehabilitation course.
Patients that had not yet undergone a neuropsychological evaluation by the time they consented to participate in the study, were administered the Orientation and Cognitive Log (OLOG/Cog-Log) to ensure they were oriented and had sufficient cognitive ability to attend to and understand instructions.
Exclusion Criteria Patients were excluded from participating in the study if they were medically unstable, as deemed by their primary doctor, were aphasic or had hemispatial neglect, had prior history of significant neurological complications or developmental delay resulting in compromised cognition, prisoners, and if they did not speak English.
Participants ABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%). Six of the 21 patients partially completed the study, but failed to complete all 8 intervention sessions. Two patients were medically withdrawn from Day Neuro due to refractory medical complications, two patients self-discharged from the program against medical advice, and two patients' rehabilitation regimens were concluded prior to their projected discharge dates when insurance or state-assisted benefits were not extended. Of the remaining 15 participants, 12 completed neuropsychological evaluation. The final analyses included 12 patients with ABI who completed VR treatment and all neuropsychological and rehabilitation outcome measures, and 12 Controls with ABI (see Figure 1).
Control Group The 12 Controls were age- and gender-matched (and etiology when possible) patients who had previously received traditional neurorehabilitation and completed the same measures as the VR group prior to onset of the study, but they did not receive VR treatment. Their data was obtained via retrospective chart review of patients admitted to Day Neuro between 04/2013 and 07/2014.
Intervention Schedule Patients completed the VR apartment program twice per week for a 4-week period (8 sessions total). The VR interventions replaced 30-60 minutes of speech therapy and/or 30-60 minutes of independent time (time designated for relaxation or completion of therapy assignments) per week of the study. Otherwise, clinical services were not altered (see Appendix 1 for detailed schedule of VR and Day Neuro therapy regimen).
The total duration of sessions 1 and 8 was approximately 60 minutes each. The duration of sessions 2-7 was 30 minutes each.
- Conditions
- Acquired Brain Injury
- Being tested
- Virtual Reality Cognitive Training
- Keywords
- Virtual Reality Exposure Therapy, Executive Function, Rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Cognitive TrainingDiagnostic test
Also called VR Group
Bimodal VR-Stroop (ClinicaVR: Apartment Stroop) Patient find themselves seated with a virtual apartment, where they see a living room, in front of a flat-screen TV set, a kitchen and a window. This intervention consisted of two Stroop conditions across all 8 sessions. In Condition 1 (Inhibition), Patients indicated when the color named (audio stimulus) matched the color shown (visual stimulus). Participants were to withhold their response in mismatched trials. In Condition 2 (Interference), Participants clicked the mouse when the color heard was the same as the ink color; not the word printed.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | ABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%). Receives: Diagnostic Test: Virtual Reality Cognitive Training |
| Control Group (Standard Care) | No intervention | The 12 Controls were age- and gender-matched (and etiology when possible) patients who had previously received traditional neurorehabilitation and completed the same measures as the VR group prior to onset of the study, but they did not receive VR treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was how quickly patient responds to a target on matching (visual color matches aurally presented color) and non-matching trials (visual color does not match aurally presented color). Metric is measured in milliseconds.
Measured: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
VR Stroop: Change in number of total commission errors
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of impulsive responses (raw score).
Measured: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
VR Stroop: Change in number of total omission errors
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of attentional errors (missed items raw score).
Measured: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
Secondary outcomes (8)
Wechsler Test of Adult Reading (WTAR)
The WTAR is a single-word reading or word pronunciation measure. It also provides an estimate of premorbid intellectual functioning. The metric of interest for the WTAR was the total score (standard score). In statistics, the standard score is the signed number of standard deviations an observation or datum is above the mean. The mean standard score for the WTAR is 100, with scores above the mean being positive, and scores below the mean being negative. This data was archival for Controls.
Measured: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Trail Making Tests (TMT)
TMT measures visuomotor processing speed, visual attention, and set-shifting. The raw score was time to completion in seconds, with lower values indicating stronger performance and higher values indicating weaker performance. This raw score was converted to a T-score. We also analyzed number of raw errors (reversals and set-shifting). This data was archival for Controls.
Measured: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Verbal Fluency Tests (COWAT and Animals)
COWAT assess phonemic fluency. Animals assessed category fluency. The raw score consists of total number correct across 3 trials for COWAT and a single trial for Animals. The raw score is converted to a T-score. This data was archival for Controls.
Measured: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Stroop Color and Word Test, Golden version
The Golden version Stroop consists of 3 trials: word reading, color naming, and inhibition. The raw score consists of the number of words or colors correctly read within 45 seconds. Lower values indicate stronger performance and higher values indicate weaker performance. The raw score for each trial is converted to a T-score. This data was archival for Controls.
Measured: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES)
Performance on the Make a Decision subtest: Accuracy Raw and Analysis of Reasoning Raw scores. Accuracy of the solution to each sub-test is scored on a scale from 0 (no viable solution) to 5 (best possible solution). Reasoning (rationale) is based on # of valid reasons included in response, with raw score equaling the # of viable options. This data was archival for Controls.
Measured: Week 1 of study and after week 4 of study.
Ross Information Processing Assessment (RIPA), 2nd Edition
Problem-Solving subtest raw score: Patient is required to respond to 10 stimuli requiring problem-solving and reasoning strategies for task completion. Organization subtest raw score: Patient is required to recall category members within a 1-minute time limit and to recall a category type given three category members. More response options generated indicates stronger performance for both subtests, with a raw score out of a maximum of 30 (X/30). This data was archival for Controls.
Measured: Week 1 of study and after week 4 of study.
Holistic Outcome Measure (HOM): Change in level of independence
The HOM assess level of independence in (1) the home, (2) the community, and (3) community participation, rated 1-5 by clinicians. A score of 1 indicates a need for full-time supervision and participation is limited to medical appointments, and 5 indicates full independence. Each category is considered independently. This data was archival for Controls.
Measured: HOM home, community, and community participation scores at discharge compared with those at admission.
Mayo-Portland Adaptability Inventory, 4th Edition (MPAI-4): Change in level of independence
MPAI-4 consists of 3 subscales: Abilities, Adjustment, Participation, which assess sensory, cognitive, and motor abilities; emotional and neurological symptoms, interpersonal adjustment, and awareness; \& social, work, and leisure participation and management of IADLs respectively. They are rated 0-4 by clinician (0 = No problem, does not interfere with activities; does not use assistive device or medication; 4 = Severe problem; interferes with activities more than 75% of the time). Each subscale is summed to produce a score, and all 3 subscores are combined to produce a total score. This data was archival for Controls.
Measured: MPAI-4 abilities, adjustment, and participation scores at discharge compared with those at admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Aug 2014
- Primary completion30 May 2015
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed design study with quasi-experimental Intervention group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Dahdah, Ph.D., Principal investigator, Baylor Scott and White Institution for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017091
- Sponsor's protocol ID
- 014-083
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Training on Executive and Complex Attentional Functions and Association With Neurorehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT04017091
- Acronym / sponsor ID
- 014-083
- Conditions
- Acquired Brain Injury
- Keywords
- Virtual Reality Exposure Therapy, Executive Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 May 2015 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 12 Jul 2019 (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.
Objective: To determine whether immersive virtual reality (VR) treatment interventions improve executive dysfunction and complex attention deficits in patients with brain injury compared with standard neurorehabilitation, and whether VR performance predicts neurorehabilitation outcomes at discharge.
Design: Mixed design study with quasi-experimental Intervention group (N = 12) and retrospective Control group (N = 12). Both groups were compromised of individuals with brain injury admitted to an outpatient day neurorehabilitation program.
Detailed description
The current study focuses on repeated practice of a VR-based cognitive intervention with the intent of improving cognitive deficits known to impact ability to resume complex activities. This study details implementation of VR within a neurorehabilitation setting. Associations between the VR Stroop and neuropsychological, speech therapy, and global rehabilitation measures are examined. The investigators include a brain injured control group to address this frequently cited methodological concern.
Inclusion Criteria Patients participating in this study were aged 18 years and older diagnosed with acquired traumatic or non-traumatic neurologic illness, and with dysfunction in executive and attention skills documented during their inpatient rehabilitation course.
Patients that had not yet undergone a neuropsychological evaluation by the time they consented to participate in the study, were administered the Orientation and Cognitive Log (OLOG/Cog-Log) to ensure they were oriented and had sufficient cognitive ability to attend to and understand instructions.
Exclusion Criteria Patients were excluded from participating in the study if they were medically unstable, as deemed by their primary doctor, were aphasic or had hemispatial neglect, had prior history of significant neurological complications or developmental delay resulting in compromised cognition, prisoners, and if they did not speak English.
Participants ABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%). Six of the 21 patients partially completed the study, but failed to complete all 8 intervention sessions. Two patients were medically withdrawn from Day Neuro due to refractory medical complications, two patients self-discharged from the program against medical advice, and two patients' rehabilitation regimens were concluded prior to their projected discharge dates when insurance or state-assisted benefits were not extended. Of the remaining 15 participants, 12 completed neuropsychological evaluation. The final analyses included 12 patients with ABI who completed VR treatment and all neuropsychological and rehabilitation outcome measures, and 12 Controls with ABI (see Figure 1).
Control Group The 12 Controls were age- and gender-matched (and etiology when possible) patients who had previously received traditional neurorehabilitation and completed the same measures as the VR group prior to onset of the study, but they did not receive VR treatment. Their data was obtained via retrospective chart review of patients admitted to Day Neuro between 04/2013 and 07/2014.
Intervention Schedule Patients completed the VR apartment program twice per week for a 4-week period (8 sessions total). The VR interventions replaced 30-60 minutes of speech therapy and/or 30-60 minutes of independent time (time designated for relaxation or completion of therapy assignments) per week of the study. Otherwise, clinical services were not altered (see Appendix 1 for detailed schedule of VR and Day Neuro therapy regimen).
The total duration of sessions 1 and 8 was approximately 60 minutes each. The duration of sessions 2-7 was 30 minutes each.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed design study with quasi-experimental Intervention group
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Diagnostic Test: Virtual Reality Cognitive TrainingABI Patients Twenty-one patients with ABI participated in this pilot study (Figure 1): 9 diagnosed with stroke (43%), 6 with TBI (29%), 2 with anoxic injury (10%), 3 with brain tumor (14%), and 1 with amyloid angiopathy (5%). |
| Control Group (Standard Care) | No intervention | –The 12 Controls were age- and gender-matched (and etiology when possible) patients who had previously received traditional neurorehabilitation and completed the same measures as the VR group prior to onset of the study, but they did not receive VR treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years and older
- Diagnosis of acquired traumatic or non-traumatic neurologic illness
- Documented dysfunction in executive and attention skills
- OLOG/Cog-Log score ≥ 25/30
Key exclusion criteria (7 listed)
- Medically unstable (as deemed by primary doctor)
- Aphasic
- Hemispatial neglect
- Prior history of significant neurological complications
- Prior history of developmental delay resulting in compromised cognition
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 Cognitive TrainingAlso: VR GroupBimodal VR-Stroop (ClinicaVR: Apartment Stroop) Patient find themselves seated with a virtual apartment, where they see a living room, in front of a flat-screen TV set, a kitchen and a window. This intervention consisted of two Stroop conditions across all 8 sessions. In Condition 1 (Inhibition), Patients indicated when the color named (audio stimulus) matched the color shown (visual stimulus). Participants were to withhold their response in mismatched trials. In Condition 2 (Interference), Participants clicked the mouse when the color heard was the same as the ink color; not the word printed. | Diagnostic test | VR Group |
Primary outcome
VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials
Time frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was how quickly patient responds to a target on matching (visual color matches aurally presented color) and non-matching trials (visual color does not match aurally presented color). Metric is measured in milliseconds.
VR Stroop: Change in number of total commission errors
Time frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of impulsive responses (raw score).
VR Stroop: Change in number of total omission errors
Time frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
The VR Stroop was administered at each of the 8 study sessions, through study completion. In both the Inhibition and the Interference Trial, the metric being measured was # of attentional errors (missed items raw score).
8 secondary outcomes
Wechsler Test of Adult Reading (WTAR)
Time frame: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Trail Making Tests (TMT)
Time frame: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Verbal Fluency Tests (COWAT and Animals)
Time frame: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Stroop Color and Word Test, Golden version
Time frame: After week 4 of study - which was typically week 5-7 of the neurorehabilitation course (Administration of traditional neuropsychological measures followed study completion to avoid confounds & practice effects). Single time point.
Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES)
Time frame: Week 1 of study and after week 4 of study.
Ross Information Processing Assessment (RIPA), 2nd Edition
Time frame: Week 1 of study and after week 4 of study.
Holistic Outcome Measure (HOM): Change in level of independence
Time frame: HOM home, community, and community participation scores at discharge compared with those at admission.
Mayo-Portland Adaptability Inventory, 4th Edition (MPAI-4): Change in level of independence
Time frame: MPAI-4 abilities, adjustment, and participation scores at discharge compared with those at admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Marie Dahdah, Ph.D. principal investigator
Baylor Scott and White Institution for Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Cognitive Training in people with Acquired Brain Injury, run by Baylor Research Institute.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials (time frame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8). The study lists 3 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 12 Jul 2019.