Contact information
Type
Scientific
Primary contact
Dr David Smithard
ORCID ID
Contact details
William Harvey Hospital
Kennington Road
Ashford
Kent
TN24 0LZ
United Kingdom
+44 (0)1233 616214
david.smithard@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov 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
Acronym
The EEG-NF Study
Study hypothesis
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
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
01/02/2009
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/02/2009
Recruitment end date
31/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
William Harvey Hospital
Kent
TN24 0LZ
United Kingdom
Sponsor information
Organisation
East Kent Hospitals University NHS Trust (UK)
Sponsor details
East Kent Hospital Trust Headquarters
Kent and Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
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
Location
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