Neurofeedback in healthy elderly at risk of cognitive decline
| ISRCTN | ISRCTN10556144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10556144 |
| Secondary identifying numbers | IN200817 |
- Submission date
- 10/06/2020
- Registration date
- 06/08/2020
- Last edited
- 17/04/2025
- Recruitment status
- Suspended
- Overall study status
- Suspended
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Age is the main risk factor for the incidence of neurocognitive disorders (such as Alzheimer’s disease, among others). Past research has shown that quantitative electroencephalography (qEEG), which measures the electrical activity of the brain using sensors placed on the scalp, might be a good tool to evaluate the risk of developing future cognitive decline in the healthy elderly population. Particularly, an excess of theta activity (4.0-8.0 Hz) has been proposed as the best predictor of cognitive decline in the absence of clinical evidence. This means that qEEG might detect if someone is at risk of developing symptoms of dementia in the medium term even when there are no symptoms at present. Moreover, among the characteristics of the EEG in aging are 1) reduction of the amplitude and frequency of the alpha rhythm, and 2) reduction of the total mean frequency. Neurofeedback teaches the individual to regulate their own brainwaves in order to improve their cognition and their behavior. In healthy seniors, downtraining of theta absolute power and uptraining of alpha peak frequency using neurofeedback have shown to be successful in terms of enhancing cognitive performance and a normalization of the EEG. The aim of this study is to find out whether downtraining the theta/alpha ratio in healthy seniors with an excess of theta absolute power will enhance their cognitive function.
Who can participate?
Healthy seniors aged 60 or older with an excess of theta absolute power compared to normal
What does the study involve?
Participants will undergo neurofeedback in order to reduce the theta/alpha ratio of their EEG. They will receive 30 sessions three times a week for an estimated total duration of 10 - 12 consecutive weeks. The partiicipants' cognitive functions will be assessed 3 months after treatment.
What are the possible benefits and risks of participating?
A possible benefit is to delay the onset of clinical symptoms associated with age-related cognitive decline. In general, the adverse effects of neurofeedback are very infrequent.
Where is the study run from?
National Autonomous University of Mexico (Mexico)
When is the study starting and how long is it expected to run for?
January 2015 to September 2023
Who is funding the study?
National Autonomous University of Mexico (Mexico)
Who is the main contact?
Dr Thalia Fernandez
thaliafh@yahoo.com.mx
Contact information
Scientific
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
 ORCID ID |
0000-0002-2842-7773 |
|---|---|
| Phone | +52 (0)442 1926101 ext 124 |
| thaliafh@yahoo.com.mx |
Scientific
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
| ORCID ID |
0000-0002-2842-7773 |
|---|---|
| Phone | +52 (0)442 1926101 ext 124 |
| thaliafh@comunidad.unam.mx |
Study information
| Study design | Single-centre non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet in Spanish. |
| Scientific title | Theta/alpha neurofeedback in healthy elderly at electroencephalographic risk of cognitive decline |
| Study acronym | NF-E-theta/alpha |
| Study objectives | Downtraining the theta/alpha ratio in healthy elderly with an excess of theta absolute power will enhance the cognitive function of those participants who successfully learn to regulate their EEG activity. |
| Ethics approval(s) | Approved 20/01/2017, Committee of Ethics of the Institute of Neurobiology (Instituto de Neurobiología, Universidad Nacional Autónoma de México, Blvd Juriquilla 3001, Queretaro, Mexico, 76230; +52 (0)442 2381002; mdiaz@comunidad.unam.mx), ref: 030.H-RM |
| Health condition(s) or problem(s) studied | Prevention of cognitive decline in healthy elderly individuals at risk |
| Intervention | The assignment of participant to the groups will be made a posteriori, based on the learning success of the treatment. Therefore, it is a non-randomised controlled trial. Participants will undergo downtraining of the Theta/Alpha ratio using neurofeedback (NFB). They will receive 30 NFB sessions three times a week, for an estimated total duration of 10 - 12 consecutive weeks. After treatment, participants will be assigned to one of two groups, according to the success in the regulation of the EEG: 1) responders and 2) non-responders. The duration of the intervention is 10-12 weeks (3 sessions/week) and follow-up will be assessed three months after treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Brain electrical activity measured using qEEG. The measure of interest will be the z-value of the Theta/Alpha ratio. Measured before training, immediately after training and 3 months after training. |
| Secondary outcome measures | 1. Brain electrical activity measured using qEEG: 1.1 Normative absolute power with geometric power correction of delta, theta, alpha and beta frequency bands in the 19 leads of the 10-20 international system referenced to linked earlobes before training, immediately after training and 3 months after training 1.2. Current Source Density distribution using e-LORETA before training, immediately after training and 3 months after training 2. Cognitive assessment: 2.1. Intelligence quotient and verbal comprehension, perceptual reasoning, working memory and processing speed indices measured using the Wechsler Adult Intelligence Scale (WAIS-IV) before training and 3 months after treatment. It is not possible to make the three timepoints evaluation due to the nature of the battery. 2.2. Attention and memory assessed using a neuropsychological battery standardized in Mexican population and with norms by age group and years of schooling (NEUROPSI-2) before training and 3 months after treatment. It is not possible to make the three timepoints evaluation due to the nature of the battery. 2.3. Executive functions assessed using a neuropsychological battery standardized in Mexican Population and with norms by age group and years of schooling (BANFE-2) before training and 3 months after treatment. It is not possible to make the three timepoints evaluation due to the nature of the battery. |
| Overall study start date | 14/01/2015 |
| Completion date | 20/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Healthy seniors aged 60 years or older 2. Right-handed 3. At least 9 years of formal schooling 4. IQ >80 (Shippley-2) 5. Normal Cognitive Assessment (MMSE >24) 6. Score of 1 or 2 in the Global Deterioration Scale 7. An excess of theta absolute power in at least one lead of their EEG (zPA[theta] > 1.96) |
| Key exclusion criteria | 1. History of psychiatric or neurological condition 2. Uncontrolled medical conditions such as hypertension, diabetes, thyroid dysfunction, hypercholesterolemia, anemia 3. General anesthesia in the year previous to enrollment in the study 4. History of cranioencephalic trauma with loss of consciousness 5. Use of drugs that are known to affect the EEG (e.g. benzodiazepines) 6. History of substance abuse (e.g. alcohol) 7. Presence of paroxysmal activity in the range of alpha frequencies |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 20/09/2022 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Queretaro
76230
Mexico
Sponsor information
University/education
Instituto de Neurobiologia
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
| Phone | +52 (0)442 2381001 |
|---|---|
| marter@unam.mx | |
| Website | http://www.inb.unam.mx |
"ROR" |
https://ror.org/01tmp8f25 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- National Autonomous University of Mexico, UNAM
- Location
- Mexico
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | A study protocol will be sent to a peer-reviewed journal once the trial registration is complete. Planned publication of the study results in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be stored in an available repository of the National Autonomous University of Mexico, following the local rules for data storage and sharing. Consent from participants are obtained and all confidentiality of the data is granted. More exact details will be made available later in the process of the study. |
Editorial Notes
17/04/2025: The protocol is currently on hold. During the COVID-19 pandemic, the researchers had to find a strategy to treat healthy older adults with excess theta activity in a non-face-to-face setting. So they began a new research project in which the training uses mindfulness (specifically MBSR) online instead of neurofeedback. They are currently evaluating its effects. Depending on the results, the researchers may or may not resume the project, considering two points: 1) that the application of MBSR does not end when the course ends, and 2) that they can reach a larger number of people at a much lower cost.
03/07/2020: Trial's existence confirmed by the Committee of Ethics of the Institute of Neurobiology.
