Virtual Reality Based Interventions After Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR/AR intervention.
- Who it may be relevant to
- Registry conditions: Acquired Brain Injury (Including Stroke). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effectiveness of Virtual Reality Based Interventions on Cognitive Function After Brain Injury
Overview
After a brain injury, cognitive impairments are common, affecting an individual's independence and quality of life. Although various training programs are used in rehabilitation, it remains unclear how effective they are in real-life settings. The project now being planned at CogTech, a technology-driven rehabilitation unit at Danderyd Hospital, aims to evaluate new methods that can enhance both training effectiveness and motivation. In the project, the effect of game-based training in virtual reality (VR) on cognition will be evaluated. VR offers a more realistic and engaging environment, which may improve the transfer of training outcomes to everyday situations. In this feasibility study, ten patients at the clinic will receive VR-training at 15 occasions in addition to rehabilitation as usual. The results may contribute to the development of more individualized rehabilitation, reduced treatment times, and improved quality of life for people with brain injury.
Detailed description
The overarching aim of this project is to evaluate the effectiveness of CogTech's technology-assisted interventions on cognitive and visual functioning in patients undergoing rehabilitation following acquired brain injury. Within the scope of this umbrella project, the initial intervention to be evaluated is VR gaming. The first aim is to investigate the feasibility of a VR-game clinical trial. The feasibility study will be conducted with approximately ten patients. The primary aim of this phase is to inform key design decisions for a subsequent RCT (including 90 patients). Specifically, the feasibility study will evaluate: the suitability of different VR games and headsets, the optimal intensity and duration of the VR-based training sessions, and the appropriate level and format of therapist involvement during the intervention.
Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital. Before enrollment in a rehabilitation program, all patients are comprehensively assessed by the rehabilitation team ("the assessment phase", with a typical duration of two to three weeks). During this phase, a neuropsychological assessment is performed by a neuropsychologist and an activity-based assessment is performed by an occupational therapist. Based on these assessments, the rehabilitation team concludes whether attention deficits are present and direct attention training is indicated (Attention Process Training11 is the standard at the clinic). Participants will be recruited among these patients. The VR intervention will be offered as an add-on to the other interventions in the rehabilitation program. The content of the rehabilitation program varies between patients, but typically includes attention process training for attention deficits, strategy training for executive deficits and physiotherapy for physical and motor deficits. The length of the rehabilitation program is typically 12 to 16 weeks.
In the feasibility study, eligible patients will consequently be informed about the study after the clinical assessment phase and will be asked for informed consent (n=10). Following the recruitment to the VR-intervention, five patients will be asked to serve as control participants. They will undergo the baseline assessment and the post-intervention assessment, but will not do the VR-based training.
Following informed consent, baseline assessments will be conducted and demographic and injury-related data will be collected. Some of the tests that will be used in the study will already have been administered as part of the clinical routine. These tests will not be re-administered in the pre-assessment. Following informed consent, the clinical psychologist who has assessed the patient will hand over the test results along with demographic and injury-related data to the responsible researcher.
Post-intervention assessments will be conducted after the 5-week training period and before the patient is discharged. All measures from the pre-assessment will be readministered, except WAIS (Wechsler Adult Intelligence Scale)-IV Matrix Reasoning, Rey Auditory Verbal Learning Task, Rey Complex Figure Task. We do not expect an intervention effect on these measures but they are potentially modifiers of treatment effect. A satisfaction questionnaire developed in house will be used and will only be administered post-intervention.
In the feasibility study, the focus will be to evaluate different VR games and headsets, the optimal intensity and duration of the VR-based training sessions, and the appropriate level and format of therapist involvement during the intervention. Results on the SIMS and the satisfaction questionnaire will be emphasized, but pre- to post changes on all measures will be calculated.
Interventions
- Behavioral VR/AR intervention
Participants will engage in cognitively demanding games such as Beat Saber, Zooma, or XR Brain Stimulation for 30-60 minutes, 3 days a week for 5 weeks using an augmented reality (AR) (RehAtt® XR) or VR headset (i.e., Meta Quest 3 or Oculus Rift S). Beat Saber and Zooma are both commercially available games. In Beat Saber players use two colored sabers to slice incoming music-synchronized blocks in the directions indicated, while also dodging obstacles like walls and bombs. Zooma involves shooti
Primary outcome measures
- WAIS-IV digit span [Time frame: before the intervention and within 3 weeks after the intervention]
- WAIS-IV Coding [Time frame: before the intervention and within 3 weeks after the intervention]
- Color-Word Interference Test [Time frame: before the intervention and within 3 weeks after the intervention]
- The Conners Continuous Performance Test (CPT)-III [Time frame: before the intervention and within 3 weeks after the intervention]
- d2 Test of Attention [Time frame: before the intervention and within 3 weeks after the intervention]
Secondary outcome measures (7)
- Hospital Anxiety and Depression Scale (HADS) [Time frame: before the intervention and within 3 weeks after the intervention]
- Mental Fatigue Scale (MFS) [Time frame: before the intervention and within 3 weeks after the intervention]
- The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [Time frame: before the intervention and within 3 weeks after the intervention]
- Canadian Occupational Performance Measurement (COPM) [Time frame: before the intervention and within 3 weeks after the intervention]
- Patient Competency Rating Scale (PCRS) [Time frame: before the intervention and within 3 weeks after the intervention]
- Situational Motivation Scale (SIMS) [Time frame: before the intervention and within 3 weeks after the intervention]
- Satisfaction questionnaire [Time frame: within 3 weeks after the intervention]
Eligibility criteria
Inclusion criteria
Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital.
Inclusion criteria
- Patients with acquired brain injury in need of multiprofessional rehabilitation admitted to the clinic are eligible if they
- are between 18 and 65 years;
- present with attention deficits and
- are deemed suitable for direct attention training by the rehabilitation team.
Exclusion criteria
- Epilepsy or suspected epilepsy;
- non-fluent in Swedish
- severe fatigue or/and cognitive dysfunction that makes participation difficult.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Danderyd Hospital — Stockholm
Identifiers
NCT: NCT07586566 · 2026-01259-01