NCT07586566

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 4, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

cognitionrehabilitationvrvirtual realityaraugmented realityacquired brain injury

Outcome Measures

Primary Outcomes (5)

  • 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

    before the intervention and within 3 weeks after the intervention

  • WAIS-IV Coding

    measures processing speed.

    before the intervention and within 3 weeks after the intervention

  • Color-Word Interference Test

    measures cognitive flexibility and selective attention.

    before the intervention and within 3 weeks after the intervention

  • The Conners Continuous Performance Test (CPT)-III

    measures sustained attention, reaction time, and impulsivity.

    before the intervention and within 3 weeks after the intervention

  • d2 Test of Attention

    measures selective and sustained attention, concentration, and processing speed

    before the intervention and within 3 weeks after the intervention

Secondary Outcomes (7)

  • Hospital Anxiety and Depression Scale (HADS)

    before the intervention and within 3 weeks after the intervention

  • Mental Fatigue Scale (MFS)

    before the intervention and within 3 weeks after the intervention

  • The Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

    before the intervention and within 3 weeks after the intervention

  • Canadian Occupational Performance Measurement (COPM)

    before the intervention and within 3 weeks after the intervention

  • Patient Competency Rating Scale (PCRS)

    before the intervention and within 3 weeks after the intervention

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

VR/AR intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Epilepsy or suspected epilepsy;
  • non-fluent in Swedish
  • severe fatigue or/and cognitive dysfunction that makes participation difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Stockholm, Stockholm County, 182 88, Sweden

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jonas Stenberg, PhD

    Danderyd Hospital / Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 14, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations