Neurocognitive Rehabilitation Using Virtual Reality

NCT04017091 | Completed FDA Device

• 1 other identifier: 014-083
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acquired Brain Injury

Keywords

Virtual Reality Exposure Therapy; Executive Function; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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).

  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)

  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)

  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)

  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

  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)

  Week 1 of study and after week 4 of study.

Other Outcomes (1)

• Simulator Sickness Questionnaire (SSQ)

  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.

Study Arms (2)

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%).

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.

Interventions

Virtual Reality Cognitive Training DIAGNOSTIC_TEST

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.

Also known as: VR Group

VR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marie Dahdah, Ph.D.

  Baylor Scott and White Institution for Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed design study with quasi-experimental Intervention group

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 12, 2019
• Study Start: August 1, 2014
• Primary Completion: May 30, 2015
• Study Completion: May 30, 2015
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share