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

NCT03686839 | Completed

• 1 other identifier: LUS2EEGNF
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment, So Stated

Keywords

Neurofeedback; Acceptance technology; Electroencephalography; MCI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SMR neurofeedback training to MCI

EXPERIMENTAL

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).

Behavioral: SMR neurofeedback training to MCI

Interventions

SMR neurofeedback training to MCI BEHAVIORAL

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.

Also known as: SMR

SMR neurofeedback training to MCI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychiatric and neurological disorders
• sensory and/or motor deficit.
• involving in another cognitive intervention

Sponsors & Collaborators

• Fabienne Marlats: lead

Study Sites (1)

Anne-Sophie Rigaud

Paris, 75013, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anne-Sophie AR Rigaud, Professor

  Broca University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neuropsychologist

Model Details: no randomized, no controlled.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 27, 2018
• Study Start: March 3, 2017
• Primary Completion: June 18, 2018
• Study Completion: July 20, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)