Condition category
Nervous System Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/01/2015
Prospective/Retrospective
Retrospectively 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 Thomas Dannhauser

ORCID ID

Contact details

The Mental Health Unit
St Margaret's Hospital
Epping
CM16 6TN
United Kingdom
+44 (0)7971 096 766
tom.dannhauser@nemhpt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0151176859

Study information

Scientific title

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

Acronym

Study hypothesis

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

Essex 1 Research Committee, 20/12/2005, ref: 05/Q0301/38

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Change in cognition and/or behaviour following treatment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

75

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2005

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Margaret's Hospital
Epping
CM16 6TN
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

North Essex Mental Health Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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