- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324178
Use of Neurofeedback to Enhance Attention After Brain Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Glasgow, United Kingdom
- Brain Injury Rehabilitation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Neurofeedback training
Sixteen 30-minute sessions of neurofeedback training performed once a day over the course of four weeks (four sessions each week)
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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.
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ACTIVE_COMPARATOR: Video game control group
Sixteen 30-minute sessions of playing video games once a day over the course of four weeks (four sessions each week)
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Sixteen 30-minute sessions of video game playing over four weeks: 7 x 3-minute blocks flanked by a 3-minute seated relaxation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attentional performance - MAAS
Time Frame: Baseline and week 4
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Change in score on Mindful Attention Awareness Scale (MAAS)
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Baseline and week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attentional performance - CTET
Time Frame: Baseline, week 4 and week 5
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Change in score on Continuous Temporal Expectancy Task (CTET)
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Baseline, week 4 and week 5
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Attentional performance - TEA
Time Frame: Baseline and week 4
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Change in score on Test of Everyday Attention (TEA) 1. 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 |
Baseline and week 4
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jon Evans, PhD, Professor of Applied Neuropsychology
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-WS-0211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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