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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment, So Stated
• Interventions: Behavioral: SMR neurofeedback training to MCI

• Registration Number: NCT03686839
• Lead Sponsor: Fabienne Marlats

Brief Summary

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.

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 Timeline

• Study Start: 2017-03-03
• Primary Completion: 2018-06-18
• Study Completion: 2018-07-20
• Status Verified: 2018-09
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMR neurofeedback training to MCI	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: 1. Preparation and installation of the electrodes, verification of the impedance, adjustment of the calibration and thresholds (15 minutes). 2. NF training (tasks and video described below) (45 minutes). 3. Feedback and debriefing about the session (15 minutes).

Primary Outcome Measures

Name	Time	Method
Neurofeedback Technology Acceptation Questionnaire	Assessment was at 2 months immediately after the Neurofeedback intervention	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.

Trial Locations

Locations (1)

Anne-Sophie Rigaud; 🇫🇷 Paris, France