Use of Neurofeedback to Enhance Attention After Brain Injury

NCT03324178 | Completed

• 1 other identifier: 17-WS-0211
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Keywords

Neurofeedback; Attention

Outcome Measures

Primary Outcomes (1)

• Attentional performance - MAAS

  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.

  Baseline and week 4

Secondary Outcomes (2)

• Attentional performance - CTET

  Baseline, week 4 and week 5

• Attentional performance - TEA

  Baseline and week 4

Study Arms (2)

Neurofeedback training

EXPERIMENTAL

Sixteen 30-minute sessions of neurofeedback training performed once a day over the course of four weeks (four sessions each week)

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)

Behavioral: Video game

Interventions

Neurofeedback training BEHAVIORAL

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.

Neurofeedback training

Video game BEHAVIORAL

Sixteen 30-minute sessions of video game playing over four weeks: 7 x 3-minute blocks flanked by a 3-minute seated relaxation.

Video game control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• Brain Injury Rehabilitation Trust: collaborator

Study Sites (1)

Brain Injury Rehabilitation Trust

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jon Evans, PhD

  Professor of Applied Neuropsychology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Neuropsychology

Model Details: A pilot two-armed, parallel-design, individually randomised controlled trial, using stratified randomization with blocking

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: February 2, 2018
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

GB (1)