Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr David Smithard


Contact details

William Harvey Hospital
Kennington Road
TN24 0LZ
United Kingdom
+44 (0)1233 616214

Additional identifiers

EudraCT number number

Protocol/serial number

EEG-NF Protocol v 1.0

Study information

Scientific title

A novel neurofeedback-based intervention to reduce neglect and improve function in stroke patients


The EEG-NF Study

Study hypothesis

The main hypothesis is that electroencephalogram-neurofeedback (EEG-NF) techniques, shown to improve attention and functional abilities in patients of comparable age and with attention deficits due to neurological diseases, will result in a sustained improvement in general attention in stroke patients with neglect. This will be associated with improvements in spatial neglect, activities of daily living and quality of life in these patients. Furthermore, EEG-NF will result in changes in the reorganisation of brain activity in these subjects, which will underpin the improvements in attention.

Ethics approval

East Kent Research Ethics Committee (REC) – approval pending as of 10/12/2008

Study design

Pragmatic open randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Stroke rehabilitation


In the intervention group, patients will receive a 30-minute session of EEG-NF training, 5 days a week for a total duration of 6 weeks (30 sessions). The EEG will be recorded from three sensors placed on the head. Signal will be acquired at 160 Hz, A/D converted and band-filtered to extract beta1 (15 - 18 Hz), SMR (12 - 15 Hz), theta (4 - 7 Hz), and 'high beta' (22 - 30 Hz). The selected frequency bands will be fed back to patients on a computer screen, via a Nexus Biofeedback System. Through this online feedback patients will learn to regulate their EEG. Enhancement or diminution of a frequency band will be shown by a contemporaneous change on the screen - an icon may move up and down the screen. Operant contingencies will be such that rewards ('points') will be gained whenever patients enhance either beta1 or SMR activity without concurrent rises in theta and high beta activity, relative to a 2-minute pre-feedback baseline. The success of patients in enhancing desired frequencies will be recorded, as will the number of sessions completed.

The control group will receive the standard treatment on stroke units for neglect, which comprises of occupational therapist supervised exercises and tasks to improve spatial attention.

Intervention type



Not Applicable

Drug names

Primary outcome measures

The Behavioural Inattention Test (BIT) measured at 6 weeks after randomisation. BIT will also be measured 12 weeks after randomisation (6 weeks after completion of EEG-NF training) to assess sustainability.

Secondary outcome measures

1. Attentional Network Test (ANT), measured 6 and 12 weeks after randomisation
2. Barthel Index (BI), measured 6 and 12 weeks after randomisation
3. Nottingham Extended Activities of Daily living (NEADL) for activity and participation, measured 6 and 12 weeks after randomisation
4. Hospital Anxiety and Depression Scale (HADS) for mood, measured 6 and 12 weeks after randomisation
5. Five dimensional EuroQol (EQ-5D) and the visual analogue scale (EQ-VAS) for quality of life, measured 6 and 12 weeks after randomisation
6. Quantitative-EEG (Q-EEG) and functional magnetic resonance imaging, measured at baseline and 6 weeks in 36 patients to investigate underlying cortical changes with recovery and intervention
7. The number of patients consenting to EEG-NF training, number completing the programme, sessions completed and ability to modulate various EEG frequencies will be documented to assess acceptability
8. Ease of use including staff training requirements and the feasibility of integrating with existing therapy programmes
9. The semi-structured interview will be analysed for patient views on benefits of treatment, acceptability of training and perceived benefits of the training programme

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Two to 12 weeks from stroke onset
2. First ever stroke
3. Right hemisphere cortical involvement, confirmed on neuroimaging
4. Significant visual neglect, defined as a behavioural inattention test (BIT) score of 129 or less (maximum possible 146)
5. No other significant cognitive or communication problem
6. Informed consent for participation and follow-up
7. Both sexes, aged 18 - 85 years

Participant type


Age group




Target number of participants

72 stroke patients with visuospatial neglect

Participant exclusion criteria

1. Unable to provide consent
2. Unable to comply with training or assessment procedures for any reason

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

William Harvey Hospital
TN24 0LZ
United Kingdom

Sponsor information


East Kent Hospitals University NHS Trust (UK)

Sponsor details

East Kent Hospital Trust Headquarters
Kent and Canterbury Hospital
Ethelbert Road
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0807-14152)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes