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Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study

Comparison of Effects Between SMR/Delta Ratio and beta1/Theta Ratio Neurofeedback Trainings for Older Adults With Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03526692
Enrollment
60
Registered
2018-05-16
Start date
2019-01-31
Completion date
2020-02-29
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment, Neurofeedback, electroencephalography, attention, memory

Brief summary

This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.

Detailed description

Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. We aim to study the effects of two neurofeedback training protocols, SMR/delta ratio and beta1/theta ratio, on cognitive performances in older adults with Mild Cognitive Impairment and to assess whether MCI patients change in brain electrical activity in a resting state after training.

Interventions

BEHAVIORALNeurofeedback

Neurofeedback experiment will consist of 30 sessions of neurofeedback training, twice or three times a week during maximum 4 months. The two experimental groups will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-training (T1) and 3 months follow-up (T2). Electroencephalography will be recorded by a technician in EEGFor each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T2 and T3.

Sponsors

Fabienne Marlats
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Comparison between three groups : two experimental groups and a control group

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of Mild Cognitive Impairment * MMSE score \>24 * Subjective memory complaint confirmed by an informant. * Perform at/or below 1.5 standard deviations from the mean for age and education-matched norms on more than one of the neuropsychological tests. * Preserve activity of daily living * Absence of dementia.

Exclusion criteria

* Psychiatric and neurological disorders * History of alcohol or other substance consumption

Design outcomes

Primary

MeasureTime frameDescription
Change on attention test, TMTB-TMABaseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-upassessment of the Trail Making Test B and A, calculation of subtraction

Secondary

MeasureTime frameDescription
Change on Rey Auditory Verbal Learning TestBaseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention, and after 3-months follow-upAssessment of verbal learning in episodic memory

Contacts

Primary ContactAnne-Sophie AR Rigaud, professor
anne-sophie.rigaud@brc.aphp.fr0033144083503
Backup ContactFabienne FM Marlats, PhD candidate
fabiennemarlats@gmail.com0033622311862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026