Clinical trial NCT04017091: Neurocognitive Rehabilitation Using Virtual Reality
Official title: The Impact of Virtual Reality Training on Executive and Complex Attentional Functions and Association With Neurorehabilitation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Virtual Reality Exposure Therapy
Executive Function
Rehabilitation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed design study with quasi-experimental Intervention group
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: VR Stroop: Change in response times from session1 to session 8 for correct and incongruent trials
timeFrame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
measure: VR Stroop: Change in number of total commission errors
timeFrame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
measure: VR Stroop: Change in number of total omission errors
timeFrame: 2 times a week for 4 weeks. VR Stroop is administered during all sessions: sessions 1-8
Secondary outcomes:
measure: Wechsler Test of Adult Reading (WTAR)
timeFrame: 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.
measure: Trail Making Tests (TMT)
timeFrame: 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.
measure: Verbal Fluency Tests (COWAT and Animals)
timeFrame: 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.
measure: Stroop Color and Word Test, Golden version
timeFrame: 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.
measure: Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES)
timeFrame: Week 1 of study and after week 4 of study.
measure: Ross Information Processing Assessment (RIPA), 2nd Edition
timeFrame: Week 1 of study and after week 4 of study.
measure: Holistic Outcome Measure (HOM): Change in level of independence
timeFrame: HOM home, community, and community participation scores at discharge compared with those at admission.
measure: Mayo-Portland Adaptability Inventory, 4th Edition (MPAI-4): Change in level of independence
timeFrame: MPAI-4 abilities, adjustment, and participation scores at discharge compared with those at admission.
Other outcomes:
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: 6 time intervals over 4 weeks (1x in week 1, 2x in week 2, 2x in week 3, 1x in week 4). During VR sessions 2-7.
Locations:
Study officials:
affiliation: Baylor Scott and White Institution for Rehabilitation
name: Marie Dahdah, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: