Condition category
Mental and Behavioural Disorders
Date applied
10/06/2020
Date assigned
06/08/2020
Last edited
30/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.inb.unam.mx

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

Publication citations

Additional files

Editorial Notes

03/07/2020: Trial's existence confirmed by Committee of Ethics of the Institute of Neurobiology.