A neurophysiological study of near infrared spectroscopy haemoencephalography neurofeedback treatment in Alzheimer's disease and related cognitive impairments

ISRCTN	ISRCTN43516338
DOI	https://doi.org/10.1186/ISRCTN43516338
Secondary identifying numbers	N0151176859

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 07/06/2017

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

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 Thomas Dannhauser
Scientific

The Mental Health Unit
St Margaret's Hospital
Epping
CM16 6TN
United Kingdom

Phone	+44 (0)7971 096 766
Email	tom.dannhauser@nemhpt.nhs.uk

Study information

Study design	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 to request a patient information sheet
Scientific title	A neurophysiological study of near infrared spectroscopy haemoencephalography neurofeedback treatment in Alzheimer's disease and related cognitive impairments
Study objectives	Can the memory and attention difficulties seen in Alzheimer's disease (AD) and its preclinical stages be treated with a biofeedback procedure that allows you to voluntarily increase blood flow and activation in specific parts of the brain?
Ethics approval(s)	Essex 1 Research Committee, 20/12/2005, ref: 05/Q0301/38
Health condition(s) or problem(s) studied	Nervous System Diseases: Alzheimer's disease
Intervention	Phase 1 - establish the neurofeedback protocols, monitor treatment effects and side effects and confirm the number of participants required for Phase 2. Phase 2 - baseline and post treatment fMRI on five groups of patients AMCI treated with NIRS-HEG biofeedback, AMCI treated with placebo NIRS-HEG biofeedback, elderly controls treated with NIRS-HEG biofeedback, mild AD treated with NIRS-HEG and mild AD treated with placebo NIRS-HEG biofeedback.
Intervention type	Other
Primary outcome measure	Change in cognition and/or behaviour following treatment.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2005
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	75
Key inclusion criteria	Phase 1: 10 patients with AMCI and 10 with mild AD Phase 2: 12-15 patients in each group depending upon the results of phase 1 of the study
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Margaret's Hospital

Epping
CM16 6TN
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

North Essex Mental Health Partnership NHS Trust (UK)

No information available

NHS R&D Support Funding

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

07/06/2017: No publications found, verifying study status with principal investigator.