Brain InjuriesNCT02399293
Computer-based Attention Training in Patients With Acquired Brain Injury
A study testing N-back and Visual Search in people with Brain Injuries, run by University of Aarhus.
Trial summary
Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- N-back and Visual Search
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Sep 2014
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects should be able to do both task at level at the time of recruitment
- Informed consent
- (for brain injured patients) training must not interfere with treatment as usual.
- (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.
Who cannot join
None listed.
About this study
Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.
- Conditions
- Brain Injuries
- Being tested
- N-back, Visual Search
- Keywords
- Cognitive training, Cognitive rehabilitation, Acquired brain injury, N-back, Visual Search, Cognitive transfer
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-backBehavioural
The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor.
Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.
Visual SearchBehavioural
The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor.
Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.
| Study group | Role | What they receive |
|---|---|---|
| Patient N-back | Experimental | Patients training the N-back task Receives: Behavioral: N-back |
| Patient Visual Search | Active comparator | Patients training the Visual-Search task Receives: Behavioral: Visual Search |
| Non-impaired N-back | Experimental | Non-impaired training the N-back task Receives: Behavioral: N-back |
| Non-impaired Visual Search | Active comparator | Non-impaired training the Visual-Search task Receives: Behavioral: Visual Search |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Raven's advanced progressive matrices at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Secondary outcomes (5)
Change from baseline WAIS-III Working Memory Index at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline WAIS-III Processing Speed Index at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Operation Span at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Stroop color-text interference at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline AMPS at the end of training
Measured: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Responsible party
- Principal investigator, Jonas Lindeløv, Aalborg University
- Investigators
- Jonas Lindeløv, M.Sc., Principal investigator, Hammel Neurocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399293
- Sponsor's protocol ID
- hnrc_nback
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Attention Training in Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02399293
- Acronym / sponsor ID
- hnrc_nback
- Conditions
- Brain Injuries
- Keywords
- Cognitive training, Cognitive rehabilitation, Acquired brain injury, N-back, Visual Search, Cognitive transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Hammel Neurocenter
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient N-back | Experimental | Behavioral: N-backPatients training the N-back task |
| Patient Visual Search | Active comparator | Behavioral: Visual SearchPatients training the Visual-Search task |
| Non-impaired N-back | Experimental | Behavioral: N-backNon-impaired training the N-back task |
| Non-impaired Visual Search | Active comparator | Behavioral: Visual SearchNon-impaired training the Visual-Search task |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects should be able to do both task at level at the time of recruitment
- Informed consent
- (for brain injured patients) training must not interfere with treatment as usual.
- (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| N-backThe N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day. | Behavioural | Non-impaired N-back, Patient N-back |
| Visual SearchThe Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day. | Behavioural | Non-impaired Visual Search, Patient Visual Search |
Primary outcome
Change from baseline Raven's advanced progressive matrices at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
5 secondary outcomes
Change from baseline WAIS-III Working Memory Index at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline WAIS-III Processing Speed Index at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Operation Span at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Stroop color-text interference at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline AMPS at the end of training
Time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
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 26 Mar 2015.
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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. This study is not recruiting at the moment.
Jonas Lindeløv, M.Sc. principal investigator
Hammel Neurocenter
Questions about this trial
What is this clinical trial studying?
A study testing N-back and Visual Search in people with Brain Injuries, run by University of Aarhus.
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 4 inclusion and 0 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change from baseline Raven's advanced progressive matrices at the end of training (time frame: within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.). 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 26 Mar 2015.