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

SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: SMR neurofeedback training to MCI

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 88 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.; Other Names: SMR; neurofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rey Auditory Verbal Learning test	Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.	Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

Collaborators and Investigators

• Sponsor: Fabienne Marlats
• Investigators: Principal Investigator: anne-Sophie AR Rigaud, Professor, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 15, 2018

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: MCI; Alzheimer; Neurofeedback; Electroencephalography
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: LUS3EEGNF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No