Clinical trial NCT03324178: Use of Neurofeedback to Enhance Attention After Brain Injury
Official title: The Effect of Neurofeedback Training on Sustained Attention and Mind Wandering Events in Patients With Brain Injury: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: Neurofeedback
Attention
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Brain Injury Rehabilitation Trust
First posted: 2017-10-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot two-armed, parallel-design, individually randomised controlled trial, using stratified randomization with blocking
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attentional performance - MAAS
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Attentional performance - CTET
timeFrame: Baseline, week 4 and week 5
measure: Attentional performance - TEA
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Brain Injury Rehabilitation Trust
Study officials:
affiliation: Professor of Applied Neuropsychology
name: Jon Evans, PhD
role: STUDY_DIRECTOR
References: