An interventional study of eRehabCog and CogMed QM in Traumatic Brain Injury, Stroke and Multiple Sclerosis, sponsored by Aniko Bartfai. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Aniko Bartfai · Not applicable, Interventional, and Treatment
Acquired brain injury and neurological disorders cause cognitive deficits, which in turn cause reduced participation in everyday life. Cognitive rehabilitation, where patients learn about cognition, cognitive deficits and ways to circumvent problems arising from deficits can increase participation and quality of life. ERehabCog is an internet delivered cognitive rehabilitation program intended for patients suffering mild to moderate impairments. The program consists of information and homework assignments, which take approximately 10 weeks to complete with the assistance of a therapist. Effects are evaluated through measures of everyday life participation, mood, and life satisfaction and compared with an attention training program. This study aims to contribute to the evidence base for internet delivered cognitive rehabilitation for mild to moderate cognitive impairments. Evidence based interventions are vital to use the potential of technology to the benefit of affected patients.
When broadly defined, diseases and injuries affecting the central nervous system are one of the leading causes of disease burden in the world affecting more than 3 billion people. With such a large proportion of the global population affected, optimization of limited resources in the form of specialized rehabilitation is instrumental to ensuring sustainable public health.
The consequences of acquired brain injuries (ABIs) and neurological disorders are multifaceted, causing diminished functional capacity in a range of areas. Cognitive impairments are common, affecting ability to work, take on reponsibilities at home and in the community. Relationships in all significant life areas can be disrupted. As a result, patients may experience a significant shift in a plurality of life roles. Rehabilitation aims to help patients recapture premorbid capacities and reduce the impact of deficits while considering the needs and context of the patient. Cognitive rehabilitation has the potential to ameliorate patient outcomes. Patients in Sweden are offered cognitive rehabilitation as a part of multimodal rehabilitation programs, typically provided in university hospital settings. The demand for such interventions is greater than the amount provided. Patients with mild cognitive deficits are generally less prioritized than those with greater impairments. Internet provided rehabilitation programs can increase the accessibility of cognitive rehabilitation.
eRehabCog is an internet-delivered 10 module cognitive rehabilitation program designed to aid patients experiencing mild to moderate cognitive deficits following acquired brain injury or neurological disorders. The philosophy behind the development of eRehabCog is grounded in a compensatory-metacognitive approach. That is to say, patients learn about cognitive functions, consequences of deficits and ways to compensate. This approach has both a practical component where patients learn strategies they may use in their everyday life and a self-reflective component where patients learn to think about their thinking in such a way to raise their awareness of their functioning.
CogMed QM is a 10 week digital working memory training program which has been evaluated in children with ADHD and adults with stroke, showing improvements in working memory function. CogMed QM is a restitutive training program, intended to help patients retake diminished working memory capacity.
The overall aim of this study is to evaluate the efficacy of eRehabCog for patients experiencing mild to moderate cognitive deficits. Specific aims are to 1) evaluate the efficacy of eRehabCog for patients with ABI and ND admitted to community neurorehabilitation 2) compare the effects of eRehabCog to CogMed QM
The study will recruit 64 patients enrolled in community neurorehabilitation. Patients recruited will be ≥ 18 years old, have obtained a score ≥ 21 on Montreal Cognitive Assessment (MoCA), living in their home, with our without assistance and with access to computer and/or functionally ecquivalent device. Exclusion criteria will be progressive neurocognitive impairment (i.e dementia), substance abuse, insufficient Swedish language capabilities, insufficiently stable living situation to commit to a 10 week long program. Community neurorehabilitation teams participating in the study will be randomized to either eRehabCog or CogMed QM.
The primary outcome measure is the Mayo Portland Adaptability Inventory - Fourth edition (MPAI-4) Participation.
Secondary outcome measures are MPAI-4 Total score, ability and adjustment, Hospital Anxiety and Depression Scale (HADS), Life Satisfaction Scale - 11 items (LiSat-11), Community Integration Questionnaire - revised (CIQ-R) and Patient Satisfaction Questionnaire (PSQ).
Background information on patients general status including socioeconomic factors and medical factors such as time since diagnosis is also collected. Behavioural measures such as time in the program, amount of messages to therapist and number of logins are additionally collected throughout participation.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 64 is above the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →This is the only study on the registry with Aniko Bartfai as lead sponsor.
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Exclusion Criteria:
10 week (1 hour / week, 10 hours in total) internet delivered manualised cognitive rehabilitation
Behavioral: eRehabCog
5 week (2 hours / week, 10 hours in total) internet delivered working memory training program
Behavioral: CogMed QM
eRehabCog is a manualised internet delivered compensatory cognitive rehabilitation program (10 weeks, 1 hour per week, 10 hours in total). It is designed to improve patient self efficacy and participation in everyday life activities through compensatory strategy learning
CogMed QM is an internet delivered training program (5 weeks, 2 hours per week, 10 hours in total) designed to improve patients working memory
Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale
Change in T-score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
MPAI-4 Adaptability subscale
Change in T-score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
MPAI-4 Abilities subscale
Change in T-score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
MPAI-4 Total score
Change in T-score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Hospital Anxiety and Depression Scale
Change in average total score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Life Satisfaction Questionnaire (LiSat-11)
Change in average total score
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Community Integration Questionnaire - Revised (CIQ-R)
Change in total and subscale scores
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Patient satisfaction questionnaire
Correlation to primary and secondary outcome measures
Time frame: End of treatment at 10 weeks
Montreal Cognitive Assessment (MoCA)
Correlation to primary and secondary outcome measures
Time frame: Baseline
Plan to share: No — According to the decision of the ethical review board, IPD can not be shared.
Started May 2021 (actual). Primary completion is estimated for Jul 2025, 49 months after the start.
Of 491 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's planned 49 months is above that.
Counting every sponsor, half of 515 studies reached it within 36 months; a quarter within 21 and three quarters within 64.
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