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

Primary Purpose

Mild Cognitive Impairment, So Stated

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SMR neurofeedback training to MCI
Sponsored by
Fabienne Marlats
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment, So Stated focused on measuring Neurofeedback, Acceptance technology, Electroencephalography, MCI

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anne-Sophie Rigaud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SMR neurofeedback training to MCI

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2018
Last Updated
September 26, 2018
Sponsor
Fabienne Marlats
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1. Study Identification

Unique Protocol Identification Number
NCT03686839
Brief Title
Feasibility Study of Neurofeedback Training for Older Adults With Mild Cognitive Impairment
Acronym
Neurofeedel
Official Title
Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabienne Marlats

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, So Stated
Keywords
Neurofeedback, Acceptance technology, Electroencephalography, MCI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
no randomized, no controlled.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMR neurofeedback training to MCI
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
SMR neurofeedback training to MCI
Other Intervention Name(s)
SMR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurofeedback Technology Acceptation Questionnaire
Description
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.
Time Frame
Assessment was at 2 months immediately after the Neurofeedback intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie AR Rigaud, Professor
Organizational Affiliation
Broca University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Anne-Sophie Rigaud
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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