Feasibility Study of Neurofeedback Training for Older Adults With Mild Cognitive Impairment (Neurofeedel)

Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment

This is a non-pharmacological study evaluating the feasibility of a neurofeedback training program in elderly with mild cognitive impairment (MCI) according to recruitment, retention, attendance, acceptability data.

Study Overview

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

Detailed Description

Neurofeedback (NF) can be counted amongst promising techniques to improve cognitive functioning if the principles of application are seriously respected, whilst recognizing the necessary adaptation to the conditions of patients with Mild Cognitive Impairment (MCI). This study examined the feasibility and acceptability of an electroencephalography neurofeedback training protocol in a sample group of older adults with MCI in order to identify the necessary conditions for an improved neurofeedback application. Participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T2) and 1-month follow-up (T3). A questionnaire about motivation, opinions of technical aspects of NF and feeling of cognitive improvement was administered at T0 and T2.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Anne-Sophie Rigaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Mild Cognitive Impairment
• Absence of history of alcohol or other substance consumption

Exclusion Criteria:

• Psychiatric and neurological disorders
• sensory and/or motor deficit.
• involving in another cognitive 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; Sensorimotor rhythm neurofeedback protocol consisted of 20 individual sessions, twice a week, during 11 weeks maximum. For each subject MCI, NF was planned and conducted by a neuropsychologist experienced in neurophysiology and neurofeedback. Each session lasted 1h10-15min and was conducted as follows: Preparation and installation of the electrodes, verification of the impedance, adjustment of the calibration and thresholds (15 minutes).; NF training (tasks and video described below) (45 minutes).; Feedback and debriefing about the session (15 minutes).

Behavioral: SMR neurofeedback training to MCI; SMR neurofeedback training consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta ratio 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 (EEGDigitrack Biofeedback plus module, Inc Elmiko Medical) was used for SMR/theta neurofeedback training.; Other Names: SMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurofeedback Technology Acceptation Questionnaire	Neurofeedback Technology Acceptation Questionnaire assessed the participants' opinions face to the electroencephalography neurofeedback intervention with 33 questions. The mode of administration was a personal interview with the investigator, the type of questions was closed-ended (for binary variable yes or no). Answers were analyzed with the Multiple Correspondence Analysis to visualize associations and similarities among participants and answers to Questionnaire. An unsupervised hierarchical clustering was performed using the Euclidean distance and Ward's method. Clusters were defined graphically using dendrogram.	Assessment was at 2 months immediately after the Neurofeedback intervention

Collaborators and Investigators

• Sponsor: Fabienne Marlats
• Investigators: Study Director: Anne-Sophie AR Rigaud, Professor, Broca University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): June 18, 2018
• Study Completion (Actual): July 20, 2018

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: MCI; Neurofeedback; Acceptance technology; Electroencephalography
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: LUS2EEGNF

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
• product manufactured in and exported from the U.S.: No