Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 155 for:    neurofeedback
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03686839
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Fabienne Marlats, Broca Hospital

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment, So Stated Behavioral: SMR neurofeedback training to MCI Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: no randomized, no controlled.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : July 20, 2018

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:

  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
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 Name: SMR




Primary Outcome Measures :
  1. Neurofeedback Technology Acceptation Questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686839


Locations
Layout table for location information
France
Anne-Sophie Rigaud
Paris, France, 75013
Sponsors and Collaborators
Fabienne Marlats
Investigators
Layout table for investigator information
Study Director: Anne-Sophie AR Rigaud, Professor Broca University Hospital

Layout table for additonal information
Responsible Party: Fabienne Marlats, Neuropsychologist, Broca Hospital
ClinicalTrials.gov Identifier: NCT03686839     History of Changes
Other Study ID Numbers: LUS2EEGNF
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fabienne Marlats, Broca Hospital:
Neurofeedback
Acceptance technology
Electroencephalography
MCI

Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders