Brain InjuriesNCT03324178
Use of Neurofeedback to Enhance Attention After Brain Injury
A study testing Neurofeedback training and Video game in people with Brain Injuries, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Difficulty to sustain attention over a prolonged period of time is one of the core difficulties experienced by people who have undergone traumatic brain injury. Rehabilitation of attention is often based on compensatory strategies, because of the limited impact of cognitive training on improving attentional capacity… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Neurofeedback training and Video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2018to 17 Jul 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- normal or corrected to normal vision
- able to provide consent
- non-progressive brain injury
- impairment of sustained attention
- stable medication regime (expected not to change during the period of the study)
- minimum computer literacy (owning a computer, laptop, tablet, ipad etc)
- native English-speakers
Who cannot join
- epilepsy
- co-morbid progressive neurological or neurodegenerative condition
- aggressive behaviour
- unhealed scalp wounds
- unable to give informed consent
- unable to cooperate with the study protocol (e.g. severe aphasia, uncorrected impairment of hearing or vision, illiteracy or unable to understand English)
- clinically unstable (e.g. due to major intercurrent illness)
- undertaking changes in the existing treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neurofeedback Training on Sustained Attention and Mind Wandering Events in Patients With Brain Injury: A Pilot Randomised Controlled Trial
Difficulty to sustain attention over a prolonged period of time is one of the core difficulties experienced by people who have undergone traumatic brain injury. Rehabilitation of attention is often based on compensatory strategies, because of the limited impact of cognitive training on improving attentional capacity after brain injury. New therapeutic approaches to explore the plastic recovery of the brain after injury, and consequent performance improvement, are warranted.
Neurofeedback (NFB) allows the self-regulation of brain activity using visual feedback. Very recently, it has been demonstrated that NFB training targeted at reducing alpha power (alpha desynchronization NFB), can induce initial plastic changes in brain networks associated with attention. It has been proposed that NFB can improve cognitive performance by tuning oscillatory activity of the brain towards a more healthy balance between neural network flexibility and stability. It is speculated that the use of alpha desynchronization NFB training, with people who present with brain injury, can enhance sustained attention in as much as the training promotes neural variability during resting state (i.e. more flexible network configuration) and neural stability during a sustained attention task (i.e. more stable network configuration).
However, before assessing the effectiveness of the intervention, it is necessary to evaluate the feasibility and acceptability thereof. This study will recruit 14 participants and randomly assign them to two groups: a NFB group and a video games control group. Long-term changes will be evaluated at two time points for both groups: baseline and post-intervention. The NFB group will have a follow-up session one week after the intervention, to evaluate whether there are long lasting changes after NFB training. In addition, short-term changes of NFB will be evaluated for the experimental group, contrasting EEG activity immediately before and after the last NFB session.
Read the detailed description
Participants taking part in the neurofeedback group will undertake sixteen 30-minute sessions of neurofeedback training, from Tuesday to Friday, distributed over the course of four weeks. Sessions will be performed at the same time each day. Each 30-min NFB session will consist of 7 x 3-minute blocks of training flanked by a 3-minute resting state block with eyes-open. During the training blocks participants will seat in front of a laptop screen displaying an image that will change according the brain activity produced by the participant. One electrode will be located at the centro parietal region of the scalp (Pz) and another one in the earlobe as a reference. Participants taking part in the control group will play video games for 30 minutes during the same number of sessions, also distributed across four weeks. The same experimental set-up will be used, but EEG activity will not be recorded. Participants will follow the same structure as the NFB group, playing video games during 7 x 3-minute blocks flanked by a 3-minute seated relaxation.
Each participant will be involved in the study for a maximum of 5 weeks. The NFB training and control sessions for all participants are expected to be completed over the course of five months.
- Conditions
- Brain Injuries
- Being tested
- Neurofeedback training, Video game
- Keywords
- Neurofeedback, Attention
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingBehavioural
Sixteen 30-minute sessions of neurofeedback training over four weeks: 7 x 3-minute blocks of training flanked by a 3-minute resting state block with eyes-open.
Video gameBehavioural
Sixteen 30-minute sessions of video game playing over four weeks: 7 x 3-minute blocks flanked by a 3-minute seated relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback training | Experimental | Sixteen 30-minute sessions of neurofeedback training performed once a day over the course of four weeks (four sessions each week) Receives: Behavioral: Neurofeedback training |
| Video game control group | Active comparator | Sixteen 30-minute sessions of playing video games once a day over the course of four weeks (four sessions each week) Receives: Behavioral: Video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional performance - MAAS
Change in score on Mindful Attention Awareness Scale (MAAS)
- Mindful Attention Awareness Scale (MAAS), (Brown et al. 2003). It is a 15-item questionnaire that assesses day-to-day experiences of mind wandering.
- Each of the 15 questions is rated with a number between 1 to 6, with 1 being "almost always" and 6 being "almost never". The total score is calculated by averaging the answers across the 15 items. The minimum score is 1 and the maximum score is 6. The questionnaire does not have subscales.
- Higher scores reflect higher levels of mindfulness, this is considered to be a better outcome. Instead, lower scores reflect higher levels of mind wandering, this is considered to be a worst outcome.
- No subscales are combined.
Measured: Baseline and week 4
Secondary outcomes (2)
Attentional performance - CTET
Change in score on Continuous Temporal Expectancy Task (CTET)
- Continuous Temporal Expectancy Task (CTET), (O'Connell 2009). It is a computerized task to evaluate sustained attention.
- Participants monitor a stream of stimuli to detect a low frequent target. They will be presented with 200 target trials in average, which corresponds approximately to the 10% of the total stimuli presented. 100% of target detection is the highest possible score.
- Higher percentage of target detection reflects better sustained attention capacity and it is considered to be a better outcome.
- No subscales are combined.
Measured: Baseline, week 4 and week 5
Attentional performance - TEA
Change in score on Test of Everyday Attention (TEA)
- Test of Every Day Attention (TEA), (Robertson et al. 1996). It is a clinical assessment of attention. In this study, only three subtests will be used that evaluate sustained attention: (1) elevator counting, (2) telephone search while counting and (3) lottery 2a. Scale range for the subtest Elevator Counting: 0 - 7. 2b. Scale Range for the subtest Telephone Search while counting: -1.0 - 17.0 (raw score).
2c. Scale Range for the subtest Lottery: 0 - 10 (raw score) 3a. Elevator Counting: A score of 7 (maximum) is considered normal. 5 or less is considered definitely abnormal.
3b. Telephone Search while counting: lower raw scores are considered better output 3c. Lottery: higher raw scores are considered better output. 4. The subscales will not be combined
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start2 Feb 2018
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot two-armed, parallel-design, individually randomised controlled trial, using stratified randomization with blocking
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Responsible party
- Principal investigator, Professor Jon Evans, University of Glasgow
- Investigators
- Jon Evans, PhD, Study director, Professor of Applied Neuropsychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324178
- Sponsor's protocol ID
- 17-WS-0211
- Status last verified
- Feb 2019
- First submitted
- 24 Oct 2017
- Last updated
- 27 Feb 2019
- 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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurofeedback Training on Sustained Attention and Mind Wandering Events in Patients With Brain Injury: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03324178
- Acronym / sponsor ID
- 17-WS-0211
- Conditions
- Brain Injuries
- Keywords
- Neurofeedback, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 27 Oct 2017 (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.
Difficulty to sustain attention over a prolonged period of time is one of the core difficulties experienced by people who have undergone traumatic brain injury. Rehabilitation of attention is often based on compensatory strategies, because of the limited impact of cognitive training on improving attentional capacity after brain injury. New therapeutic approaches to explore the plastic recovery of the brain after injury, and consequent performance improvement, are warranted.
Neurofeedback (NFB) allows the self-regulation of brain activity using visual feedback. Very recently, it has been demonstrated that NFB training targeted at reducing alpha power (alpha desynchronization NFB), can induce initial plastic changes in brain networks associated with attention. It has been proposed that NFB can improve cognitive performance by tuning oscillatory activity of the brain towards a more healthy balance between neural network flexibility and stability. It is speculated that the use of alpha desynchronization NFB training, with people who present with brain injury, can enhance sustained attention in as much as the training promotes neural variability during resting state (i.e. more flexible network configuration) and neural stability during a sustained attention task (i.e. more stable network configuration).
However, before assessing the effectiveness of the intervention, it is necessary to evaluate the feasibility and acceptability thereof. This study will recruit 14 participants and randomly assign them to two groups: a NFB group and a video games control group. Long-term changes will be evaluated at two time points for both groups: baseline and post-intervention. The NFB group will have a follow-up session one week after the intervention, to evaluate whether there are long lasting changes after NFB training. In addition, short-term changes of NFB will be evaluated for the experimental group, contrasting EEG activity immediately before and after the last NFB session.
Detailed description
Participants taking part in the neurofeedback group will undertake sixteen 30-minute sessions of neurofeedback training, from Tuesday to Friday, distributed over the course of four weeks. Sessions will be performed at the same time each day. Each 30-min NFB session will consist of 7 x 3-minute blocks of training flanked by a 3-minute resting state block with eyes-open. During the training blocks participants will seat in front of a laptop screen displaying an image that will change according the brain activity produced by the participant. One electrode will be located at the centro parietal region of the scalp (Pz) and another one in the earlobe as a reference. Participants taking part in the control group will play video games for 30 minutes during the same number of sessions, also distributed across four weeks. The same experimental set-up will be used, but EEG activity will not be recorded. Participants will follow the same structure as the NFB group, playing video games during 7 x 3-minute blocks flanked by a 3-minute seated relaxation.
Each participant will be involved in the study for a maximum of 5 weeks. The NFB training and control sessions for all participants are expected to be completed over the course of five months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot two-armed, parallel-design, individually randomised controlled trial, using stratified randomization with blocking
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback training | Experimental | Behavioral: Neurofeedback trainingSixteen 30-minute sessions of neurofeedback training performed once a day over the course of four weeks (four sessions each week) |
| Video game control group | Active comparator | Behavioral: Video gameSixteen 30-minute sessions of playing video games once a day over the course of four weeks (four sessions each week) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- normal or corrected to normal vision
- able to provide consent
- non-progressive brain injury
- impairment of sustained attention
- stable medication regime (expected not to change during the period of the study)
Key exclusion criteria (8 listed)
- epilepsy
- co-morbid progressive neurological or neurodegenerative condition
- aggressive behaviour
- unhealed scalp wounds
- unable to give informed consent
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 |
|---|---|---|
| Neurofeedback trainingSixteen 30-minute sessions of neurofeedback training over four weeks: 7 x 3-minute blocks of training flanked by a 3-minute resting state block with eyes-open. | Behavioural | Neurofeedback training |
| Video gameSixteen 30-minute sessions of video game playing over four weeks: 7 x 3-minute blocks flanked by a 3-minute seated relaxation. | Behavioural | Video game control group |
Primary outcome
Attentional performance - MAAS
Time frame: Baseline and week 4
Change in score on Mindful Attention Awareness Scale (MAAS) 1. Mindful Attention Awareness Scale (MAAS), (Brown et al. 2003). It is a 15-item questionnaire that assesses day-to-day experiences of mind wandering. 2. Each of the 15 questions is rated with a number between 1 to 6, with 1 being "almost always" and 6 being "almost never". The total score is calculated by averaging the answers across the 15 items. The minimum score is 1 and the maximum score is 6. The questionnaire does not have subscales. 3. Higher scores reflect higher levels of mindfulness, this is considered to be a better outcome. Instead, lower scores reflect higher levels of mind wandering, this is considered to be a worst outcome. 4. No subscales are combined.
2 secondary outcomes
Attentional performance - CTET
Time frame: Baseline, week 4 and week 5
Attentional performance - TEA
Time frame: Baseline and week 4
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 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jon Evans, PhD study director
Professor of Applied Neuropsychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training and Video game in people with Brain Injuries, run by University of Glasgow at 1 site in United Kingdom.
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 7 inclusion and 8 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 27 Feb 2019. 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 United Kingdom. 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?
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?
Attentional performance - MAAS (time frame: Baseline and week 4). 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 27 Feb 2019.