Traumatic Brain InjuryeRehabCogNCT06973018
Internet Delivered Cognitive Rehabilitation for Mild Cognitive Impairments
A study testing eRehabCog and CogMed QM in people with Traumatic Brain Injury and Stroke, run by Aniko Bartfai at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Stroke, Multiple Sclerosis
- What is being tested?
- eRehabCog and CogMed QM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2021to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in community neurorehabilitation in Stockholm, Sweden
- Mild to moderate cognitive impairment as a consequence of acquired brain injury or nervous system disease
- MoCA 21 ≥
- Sufficient command of Swedish language
- Access to internet connected device and internet connection
Who cannot join
- Severe and enduring psychiatric or behavioural disorders (i.e Schizophrenia, substance abuse)
- Suspected or diagnosed dementia
- Homelessness or other social instability rendering access to internet unpredictable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Internetförmedlad Kognitiv Rehabilitering Vid Lindrig Kognitiv störning
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.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury, Stroke, Multiple Sclerosis, Parkinsons Disease (PD), Post-COVID-19 Condition
- Being tested
- eRehabCog, CogMed QM
- Keywords
- brain injury, cognitive rehabilitation, nervous system disorders, eHealth, self assessment
- Medical subject headings
- Brain Injuries, Traumatic, Stroke, Multiple Sclerosis, Parkinson Disease, Brain Injuries, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eRehabCogBehavioural
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 QMBehavioural
CogMed QM is an internet delivered training program (5 weeks, 2 hours per week, 10 hours in total) designed to improve patients working memory
| Study group | Role | What they receive |
|---|---|---|
| eRehabCog | Experimental | 10 week (1 hour / week, 10 hours in total) internet delivered manualised cognitive rehabilitation Receives: Behavioral: eRehabCog |
| CogMed QM | Active comparator | 5 week (2 hours / week, 10 hours in total) internet delivered working memory training program Receives: Behavioral: CogMed QM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale
Change in T-score
Measured: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Secondary outcomes (6)
MPAI-4 Adaptability subscale
Change in T-score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start2 May 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating teams were randomized to either of the two intervention arms.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aniko Bartfai
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor-investigator, Aniko Bartfai, Danderyd Hospital
- Investigators
- Aniko Bartfai, PhD, Principal investigator, Karolinska Institutet Danderyds Sjukhus (KIDS), Department of medical rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973018
- Sponsor's protocol ID
- Dnr 202003079
- Acronym
- eRehabCog
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the decision of the ethical review board, IPD can not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internetförmedlad Kognitiv Rehabilitering Vid Lindrig Kognitiv störning
- ClinicalTrials.gov ID
- NCT06973018
- Acronym / sponsor ID
- eRehabCog / Dnr 202003079
- Conditions
- Traumatic Brain Injury, Stroke, Multiple Sclerosis, Parkinsons Disease (PD), Post-COVID-19 Condition
- Keywords
- brain injury, cognitive rehabilitation, nervous system disorders, eHealth, self assessment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aniko BartfaiUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 2 May 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating teams were randomized to either of the two intervention arms.
| Arm | Type | Receives |
|---|---|---|
| eRehabCog | Experimental | Behavioral: eRehabCog10 week (1 hour / week, 10 hours in total) internet delivered manualised cognitive rehabilitation |
| CogMed QM | Active comparator | Behavioral: CogMed QM5 week (2 hours / week, 10 hours in total) internet delivered working memory training program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrolled in community neurorehabilitation in Stockholm, Sweden
- Mild to moderate cognitive impairment as a consequence of acquired brain injury or nervous system disease
- MoCA 21 ≥
- Sufficient command of Swedish language
- Access to internet connected device and internet connection
Key exclusion criteria (3 listed)
- Severe and enduring psychiatric or behavioural disorders (i.e Schizophrenia, substance abuse)
- Suspected or diagnosed dementia
- Homelessness or other social instability rendering access to internet unpredictable
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 |
|---|---|---|
| eRehabCogeRehabCog 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 | Behavioural | eRehabCog |
| CogMed QMCogMed QM is an internet delivered training program (5 weeks, 2 hours per week, 10 hours in total) designed to improve patients working memory | Behavioural | CogMed QM |
Primary outcome
Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Change in T-score
6 secondary outcomes
MPAI-4 Adaptability subscale
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
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
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
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)
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)
Time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
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 15 May 2025.
- Description of eRehabCog in text and video format (Swedish)Link provided by the sponsor.
- Description of Cogmed QM from company webpage (English and Swedish)Link provided by the sponsor.
- Individual participant dataSharing planned: No. According to the decision of the ethical review board, IPD can not be shared.
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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.
Aniko Bartfai, PhD principal investigator
Karolinska Institutet Danderyds Sjukhus (KIDS), Department of medical rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eRehabCog and CogMed QM in people with Traumatic Brain Injury and Stroke, run by Aniko Bartfai 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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale (time frame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed). 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 15 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.