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

Mild Cognitive Impairment, So Stated Clinical Trial

— Neurofeedel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686839
• Other study ID #: LUS2EEGNF
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: September 2018
• Source: Broca Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 20, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment, So Stated

Intervention

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.

Locations

Country	Name	City	State
France	Anne-Sophie Rigaud	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fabienne Marlats

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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