Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Thalia Fernandez
ORCID ID
http://orcid.org/0000-0002-2842-7773
Contact details
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
+52 (0)442 1926101 ext 124
thaliafh@yahoo.com.mx
Type
Scientific
Additional contact
Dr Thalia Fernandez
ORCID ID
http://orcid.org/0000-0002-2842-7773
Contact details
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
+52 (0)442 1926101 ext 124
thaliafh@comunidad.unam.mx
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IN200817
Study information
Scientific title
Theta/alpha neurofeedback in healthy elderly at electroencephalographic risk of cognitive decline
Acronym
NF-E-theta/alpha
Study hypothesis
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
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
Study design
Single-centre non-randomized controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet in Spanish.
Condition
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
Phase
Drug names
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 trial start date
14/01/2015
Overall trial end date
20/09/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy seniors aged 60 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)
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/11/2020
Recruitment end date
20/09/2022
Locations
Countries of recruitment
Mexico
Trial participating centre
Instituto de Neurobiologia, Universidad Nacional Autonoma de Mexico
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
Sponsor information
Organisation
National Autonomous University of Mexico
Sponsor details
Instituto de Neurobiologia
Blvd. Juriquilla 3001
Queretaro
76230
Mexico
+52 (0)442 2381001
marter@unam.mx
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universidad Nacional Autónoma de México
Alternative name(s)
National Autonomous University of Mexico, UNAM
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Mexico
Results and Publications
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 statement
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.
Intention to publish date
30/06/2024
Participant level data
Stored in repository
Basic results (scientific)
Publication list