Electroencephalogram-neurofeedback (EEG-NF) to improve neglect in stroke patients

ISRCTN	ISRCTN85291842
DOI	https://doi.org/10.1186/ISRCTN85291842
Secondary identifying numbers	EEG-NF Protocol v 1.0

Submission date: 01/10/2008
Registration date: 10/12/2008
Last edited: 13/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Smithard
Scientific

William Harvey Hospital
Kennington Road
Ashford
Kent
TN24 0LZ
United Kingdom

Phone	+44 (0)1233 616214
Email	david.smithard@nhs.net

Study information

Study design	Pragmatic open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A novel neurofeedback-based intervention to reduce neglect and improve function in stroke patients
Study acronym	The EEG-NF Study
Study objectives	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(s)	East Kent Research Ethics Committee (REC) approval pending as of 10/12/2008
Health condition(s) or problem(s) studied	Stroke rehabilitation
Intervention	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	Other
Primary outcome measure	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 study start date	01/02/2009
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	72 stroke patients with visuospatial neglect
Key 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
Key exclusion criteria	1. Unable to provide consent 2. Unable to comply with training or assessment procedures for any reason
Date of first enrolment	01/02/2009
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

William Harvey Hospital

Kent
TN24 0LZ
United Kingdom

Sponsor information

East Kent Hospitals University NHS Trust (UK)
Hospital/treatment centre

East Kent Hospital Trust Headquarters
Kent and Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
England
United Kingdom

Website	http://www.ekht.nhs.uk/
"ROR"	https://ror.org/02dqqj223

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/04/2017: No publications found in PubMed, verifying study status with principal investigator