Acquired Brain Injury (Including Stroke)NCT07586566
Virtual Reality Based Interventions After Brain Injury
A study testing VR/AR intervention in people with Acquired Brain Injury (Including Stroke), run by Danderyd Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- What is being tested?
- VR/AR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital.
- 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.
Who cannot join
- Epilepsy or suspected epilepsy;
- non-fluent in Swedish
- severe fatigue or/and cognitive dysfunction that makes participation difficult.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Danderyd Hospital
Stockholm, Stockholm County, 182 88
Jonas Stenberg, PhD, 00462699536, jonas.stenberg@regionstockholm.se
About this study
Official title: The Effectiveness of Virtual Reality Based Interventions on Cognitive Function After Brain Injury
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.
Read the 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.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- VR/AR intervention
- Keywords
- cognition, rehabilitation, vr, virtual reality, ar, augmented reality, acquired brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR/AR interventionBehavioural
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 shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings.
| Study group | Role | What they receive |
|---|---|---|
| VR/AR intervention | Active comparator | 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 shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings. Receives: Behavioral: VR/AR intervention |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
WAIS-IV digit span
Digit span forwards measures short-term memory, attention and auditory processing ability. Digit span backwards measures working memory and mental processing ability
Measured: before the intervention and within 3 weeks after the intervention
WAIS-IV Coding
measures processing speed.
Measured: before the intervention and within 3 weeks after the intervention
Color-Word Interference Test
measures cognitive flexibility and selective attention.
Measured: before the intervention and within 3 weeks after the intervention
The Conners Continuous Performance Test (CPT)-III
measures sustained attention, reaction time, and impulsivity.
Measured: before the intervention and within 3 weeks after the intervention
d2 Test of Attention
measures selective and sustained attention, concentration, and processing speed
Measured: before the intervention and within 3 weeks after the intervention
Secondary outcomes (7)
Hospital Anxiety and Depression Scale (HADS)
a 14-item questionnaire used to screen for symptoms of anxiety and depression, particularly in medical settings.
Measured: before the intervention and within 3 weeks after the intervention
Mental Fatigue Scale (MFS)
a 15-item self-report questionnaire used to assess mental fatigue, often after brain injury, neurological illness, or concussion. It measures difficulties such as fatigue, lack of initiative, mental
Measured: before the intervention and within 3 weeks after the intervention
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
a 16-item self-report tool used to measure the severity of post-concussion symptoms after a traumatic brain injury.
Measured: before the intervention and within 3 weeks after the intervention
Canadian Occupational Performance Measurement (COPM)
is a is a client-centered assessment that identifies daily activities a person wants, needs, or is expected to do but has difficulty performing. It uses a structured interview to help the client rate the importance, performance, and satisfaction of chosen activities. The scores are then used to guide treatment and measure change over time.
Measured: before the intervention and within 3 weeks after the intervention
Patient Competency Rating Scale (PCRS)
is a 30-item questionnaire in which the respondent on a 5-point Likert scale rate his or her degree of difficulty in a variety of everyday tasks.
Measured: before the intervention and within 3 weeks after the intervention
Situational Motivation Scale (SIMS)
consist of 16 items and measures intrinsic and extrinsic motivation in different situations and activities.
Measured: before the intervention and within 3 weeks after the intervention
Satisfaction questionnaire
A satisfaction questionnaire developed in-house
Measured: within 3 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Promobila
- Responsible party
- Principal investigator, Jonas Stenberg, Danderyd Hospital
- Investigators
- Jonas Stenberg, PhD, Principal investigator, Danderyd Hospital / Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586566
- Sponsor's protocol ID
- 2026-01259-01
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to swedish legislation
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality Based Interventions on Cognitive Function After Brain Injury
- ClinicalTrials.gov ID
- NCT07586566
- Acronym / sponsor ID
- 2026-01259-01
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- cognition, rehabilitation, vr, virtual reality, ar, augmented reality, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Promobila
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 May 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR/AR intervention | Active comparator | Behavioral: VR/AR interventionParticipants 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 shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings. |
| Control | No 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital.
- 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.
Key exclusion criteria (3 listed)
- Epilepsy or suspected epilepsy;
- non-fluent in Swedish
- severe fatigue or/and cognitive dysfunction that makes participation difficult.
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 |
|---|---|---|
| VR/AR interventionParticipants 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 shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings. | Behavioural | VR/AR intervention |
Primary outcome
WAIS-IV digit span
Time frame: before the intervention and within 3 weeks after the intervention
Digit span forwards measures short-term memory, attention and auditory processing ability. Digit span backwards measures working memory and mental processing ability
WAIS-IV Coding
Time frame: before the intervention and within 3 weeks after the intervention
measures processing speed.
Color-Word Interference Test
Time frame: before the intervention and within 3 weeks after the intervention
measures cognitive flexibility and selective attention.
The Conners Continuous Performance Test (CPT)-III
Time frame: before the intervention and within 3 weeks after the intervention
measures sustained attention, reaction time, and impulsivity.
d2 Test of Attention
Time frame: before the intervention and within 3 weeks after the intervention
measures selective and sustained attention, concentration, and processing speed
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided. Due to swedish legislation
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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.
Jonas Stenberg, PhD principal investigator
Danderyd Hospital / Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR/AR intervention in people with Acquired Brain Injury (Including Stroke), run by Danderyd Hospital at 1 site in Sweden.
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 5 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: opening soon, as of the sponsor's last update on 14 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Stenberg, PhD (0046702699536, jonas.stenberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WAIS-IV digit span (time frame: before the intervention and within 3 weeks after the intervention). The study lists 5 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 14 May 2026.