Clinical trial NCT03526692: Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Neurofeedback
electroencephalography
attention
memory
Lead sponsor: Broca Hospital
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between three groups : two experimental groups and a control group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on attention test, TMTB-TMA
timeFrame: Baseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-up
Secondary outcomes:
measure: Change on Rey Auditory Verbal Learning Test
timeFrame: Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention, and after 3-months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Broca University Hospital
name: Anne-Sophie AR Rigaud, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marlats F, Bao G, Chevallier S, Boubaya M, Djabelkhir-Jemmi L, Wu YH, Lenoir H, Rigaud AS, Azabou E. SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Front Aging Neurosci. 2020 Jun 16;12:147. doi: 10.3389/fnagi.2020.00147. eCollection 2020.
citation: Marlats F, Djabelkhir-Jemmi L, Azabou E, Boubaya M, Pouwels S, Rigaud AS. Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial. Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.