Use of Neurofeedback to Enhance Attention After Brain Injury

NCT ID: NCT03324178

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2018-07-17

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.

Conditions

Brain Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Neurofeedback training

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

Group Type: EXPERIMENTAL

Neurofeedback training

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Video game

Intervention Type: BEHAVIORAL

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

Interventions

Neurofeedback training

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.

Intervention Type: BEHAVIORAL

Video game

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain Injury Rehabilitation Trust

OTHER

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

Professor Jon Evans

Professor of Applied Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Evans, PhD

Role: STUDY_DIRECTOR

Professor of Applied Neuropsychology

Locations

Brain Injury Rehabilitation Trust

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

17-WS-0211

Identifier Type: -

Identifier Source: org_study_id