CClinicalTrials.gg
CompletedNCT03855319NeurofeedelUpdated Feb 28, 2019

Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment

An interventional study of SMR neurofeedback training to MCI in Mild Cognitive Impairment, sponsored by Fabienne Marlats. Completed. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by Fabienne Marlats · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Dec 2016, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
65 Years to 90 Years
Sex
All
01

Study summary

This is a non-pharmacological pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.

Read the detailed description

Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in elderly with mild cognitive impairment. In this pilot study, the investigators studied whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain electrical activity in a sample group of elderly patients with mild cognitive impairment. Twenty participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T1) and 1-month follow-up (T2).

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Neurofeedback
  • Electroencephalography
  • MCI
  • Alzheimer
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 20 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Fabienne Marlats is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of Mild Cognitive Impairment
  • education level of 9 years of studies minimum
  • righthandedness
  • subjective memory complaint confirmed by an informant
  • a Mini Mental Status Examination score >20.
  • preserve activity of daily living and absence of dementia.

Exclusion criteria

Exclusion Criteria:

  • elderly persons who were under guardianship
  • resident in nursing facilities
  • neurological disease, psychiatric disease
  • and involved in another cogniitve intervention.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    SMR neurofeedback training to MCI

    A sensorimotor/theta neurofeedback training consisted of 20 individuals sessions, twice a week during 11 weeks maximum. For each subject, NF was planned and conducted by a neuropsychologist experienced in neurophysiology an neurofeedback. Each session lasted 1h10 minutes and was conducted as follows: * Preparation and installation of the electrodes, verification of the impedance, adjustement of the calibration. * NF training (tasks and video described below)(45minutes) * Feedback and debriefing about the session (15 minutes)

    Behavioral: SMR neurofeedback training to MCI

Interventions

  • BehavioralSMR neurofeedback training to MCI

    The intervention consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta training was recorded at channel Cz according to the international 10-20 system. Theta rhythm was also recorded and, in this case, SMR was stimulated while theta waves were suppressed.A 32 channels system (EEGDigitrcak Biofeedback plus module, Inc Elmiko Medical) was used for the SMR/theta Neurofeedback training.

    Also known as: SMR, neurofeedback

06

What researchers measure

Primary outcomes

  1. Rey Auditory Verbal Learning test

    Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.

    Time frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

Secondary outcomes

  1. Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.

    Electroencephalography was recorded and EEG power spectrum was calculated using the fast Fourier transform. The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.

    Time frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03855319
Lead sponsor
Fabienne Marlats
Responsible party
Fabienne Marlats (Neuropsychologist, Broca Hospital) — Sponsor-investigator
First posted
Feb 26, 2019
Start date
Dec 15, 2016
Primary completion
Dec 15, 2018
Completion
Dec 15, 2018
Last update
Feb 28, 2019

Study contacts

anne-Sophie AR Rigaud, Professor
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion