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ISRCTN
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ISRCTN85291842
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ClinicalTrials.gov identifier
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Public title
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Electroencephalogram-neurofeedback (EEG-NF) to improve neglect in stroke patients
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Scientific title
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A novel neurofeedback-based intervention to reduce neglect and improve function in stroke patients
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Acronym
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The EEG-NF Study
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Serial number at source
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EEG-NF Protocol v 1.0
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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East Kent Research Ethics Committee (REC) approval pending as of 10/12/2008.
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Study design
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Pragmatic open randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke rehabilitation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Unable to provide consent
2. Unabale to comply with training or assessment procedures for any reason
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Anticipated start date
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01/02/2009
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Anticipated end date
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31/01/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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72 stroke patients with visuospatial neglect
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0807-14152)
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Trial website
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Publications
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Contact name
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Dr
David
Smithard
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Address
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William Harvey Hospital
Kennington Road
Ashford
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City/town
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Kent
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Zip/Postcode
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TN24 0LZ
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Country
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United Kingdom
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Tel
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+44 (0)1233 616214
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Email
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david.smithard@nhs.net
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Sponsor
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East Kent Hospitals University NHS Trust (UK)
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Address
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East Kent Hospital Trust Headquarters
Kent and Canterbury Hospital
Ethelbert Road
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City/town
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Canterbury
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Zip/Postcode
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CT1 3NG
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Country
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United Kingdom
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Sponsor website:
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http://www.ekht.nhs.uk/
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Date applied
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01/10/2008
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Last edited
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10/12/2008
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Date ISRCTN assigned
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10/12/2008
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