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 |
| Protocol serial number | N0151176859 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | North Essex Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding |
- 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
Scientific
The Mental Health Unit
St Margaret's Hospital
Epping
CM16 6TN
United Kingdom
| Phone | +44 (0)7971 096 766 |
|---|---|
| tom.dannhauser@nemhpt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Change in cognition and/or behaviour following treatment. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St Margaret's Hospital
Epping
CM16 6TN
United Kingdom
CM16 6TN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/06/2017: No publications found, verifying study status with principal investigator.
