Acquired Brain InjuryNCT03558308
CBCR for Executive Functions in Patients With ABI in the Chronic Phase
A study testing Computer based cognitive rehabilitation in people with Acquired Brain Injury and Cognitive Symptom, run by Katrine Sværke at 1 site in Denmark.
Trial summary
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Brain Injury, Cognitive Symptom, Executive Dysfunction
- What is being tested?
- Computer based cognitive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons who are able to give an informed consent both verbally and in writing
- Persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset)
- Persons who score less than the 30. Percentile in one or more of the primary outcome measures outlined above.
Who cannot join
- Persons with neurodegenerative diseases
- Persons with diseases which can influence executive functions such as ADHD
- Persons who are motorically or cognitively unable to use a tablet and complete the CBCR-training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury
Read the detailed description
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. Furthermore, the study consists of Groups that receives the computerized training both with and witouth support from a professional.
- Being tested
- Computer based cognitive rehabilitation, Sham computerized gaming
- Medical subject headings
- Brain Injuries, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer based cognitive rehabilitationBehavioural
Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.
Sham computerized gamingOther
Sham training with generally stimulating computer-games
| Study group | Role | What they receive |
|---|---|---|
| Brain+ with clinical support | Experimental | Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period. Receives: Behavioral: Computer based cognitive rehabilitation |
| Cogmed with continuous support | Experimental | Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period. Receives: Behavioral: Computer based cognitive rehabilitation |
| Brain+ without support | Experimental | Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period. Receives: Behavioral: Computer based cognitive rehabilitation |
| Sham-training group | Sham comparator | Intervention: Sham computerized gaming. This group will train computerized solitaire and other computerized games which are thought to be generally cognitive stimulating but with a very limit load on executive functions. This group will receive continuous support during the intervention period. Receives: Other: Sham computerized gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASAT
Paced auditory serial addition test, test of verbal working memory
Measured: 3 seconds
Trail making test A+B
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts
Measured: 5 minutes
Secondary outcomes (8)
SDMT
Symbol digit modalities test: Test of processing speed
Measured: 90 seconds
Word fluency test
Test of verbal fluency
Measured: 1 min
Digit span (WAIS-IV)
Test of verbal memory (forward) and working memory (backward)
Measured: 5 minutes
Spatial span (WMS-III)
Test of visuospatial memory (forward) and visuospatial working memory (backward)
Measured: 5 minutes
Stroop colour and word test
Test of inhibition
Measured: 3 minutes
BNI-FS
Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury
Measured: 10 minutes
Quality of Life after Brain Injury (QOLIBRI)
Questionnaire about quality of life
Measured: 10 minutes
Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Verbal memory test
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Aug 2018
- Primary completion1 Jan 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katrine Sværke
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Katrine Sværke, Bispebjerg Hospital
- Investigators
- Jesper Mogensen, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558308
- Sponsor's protocol ID
- H-18006890
- Status last verified
- Jul 2021
- First submitted
- 3 Jun 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study
- ClinicalTrials.gov ID
- NCT03558308
- Acronym / sponsor ID
- H-18006890
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Katrine SværkeUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 15 Jun 2018 (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.
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury
Detailed description
This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. Furthermore, the study consists of Groups that receives the computerized training both with and witouth support from a professional.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brain+ with clinical support | Experimental | Behavioral: Computer based cognitive rehabilitationIntervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period. |
| Cogmed with continuous support | Experimental | Behavioral: Computer based cognitive rehabilitationIntervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period. |
| Brain+ without support | Experimental | Behavioral: Computer based cognitive rehabilitationIntervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period. |
| Sham-training group | Sham comparator | Other: Sham computerized gamingIntervention: Sham computerized gaming. This group will train computerized solitaire and other computerized games which are thought to be generally cognitive stimulating but with a very limit load on executive functions. This group will receive continuous support during the intervention period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Persons who are able to give an informed consent both verbally and in writing
- Persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset)
- Persons who score less than the 30. Percentile in one or more of the primary outcome measures outlined above.
Key exclusion criteria (3 listed)
- Persons with neurodegenerative diseases
- Persons with diseases which can influence executive functions such as ADHD
- Persons who are motorically or cognitively unable to use a tablet and complete the CBCR-training
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 |
|---|---|---|
| Computer based cognitive rehabilitationComputer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury. | Behavioural | Brain+ with clinical support, Brain+ without support, Cogmed with continuous support |
| Sham computerized gamingSham training with generally stimulating computer-games | Other | Sham-training group |
Primary outcome
PASAT
Time frame: 3 seconds
Paced auditory serial addition test, test of verbal working memory
Trail making test A+B
Time frame: 5 minutes
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts
8 secondary outcomes
SDMT
Time frame: 90 seconds
Word fluency test
Time frame: 1 min
Digit span (WAIS-IV)
Time frame: 5 minutes
Spatial span (WMS-III)
Time frame: 5 minutes
Stroop colour and word test
Time frame: 3 minutes
BNI-FS
Time frame: 10 minutes
Quality of Life after Brain Injury (QOLIBRI)
Time frame: 10 minutes
Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
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. This study is not recruiting at the moment.
Jesper Mogensen, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer based cognitive rehabilitation in people with Acquired Brain Injury and Cognitive Symptom, run by Katrine Sværke at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 22 Jul 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PASAT (time frame: 3 seconds). The study lists 2 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 22 Jul 2021.