Condition category
Circulatory System
Date applied
01/10/2008
Date assigned
10/12/2008
Last edited
24/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

http://www.ekht.nhs.uk/

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

Publication citations

Additional files

Editorial Notes