Back to resultsNeurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment (Neurofeedel)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMR neurofeedback training to MCI
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Neurofeedback, Electroencephalography, MCI, Alzheimer
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Mild Cognitive Impairment
- education level of 9 years of studies minimum
- righthandedness
- subjective memory complaint confirmed by an informant
- a Mini Mental Status Examination score >20.
- preserve activity of daily living and absence of dementia.
Exclusion Criteria:
- elderly persons who were under guardianship
- resident in nursing facilities
- neurological disease, psychiatric disease
- and involved in another cogniitve intervention.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMR neurofeedback training to MCI
Arm Description
A sensorimotor/theta neurofeedback training consisted of 20 individuals sessions, twice a week during 11 weeks maximum. For each subject, NF was planned and conducted by a neuropsychologist experienced in neurophysiology an neurofeedback. Each session lasted 1h10 minutes and was conducted as follows: Preparation and installation of the electrodes, verification of the impedance, adjustement of the calibration. NF training (tasks and video described below)(45minutes) Feedback and debriefing about the session (15 minutes)
Outcomes
Primary Outcome Measures
Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.
Secondary Outcome Measures
Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
Electroencephalography was recorded and EEG power spectrum was calculated using the fast Fourier transform. The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03855319
Brief Title
Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment
Acronym
Neurofeedel
Official Title
SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 15, 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 pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.
Detailed Description
Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in elderly with mild cognitive impairment. In this pilot study, the investigators studied whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain electrical activity in a sample group of elderly patients with mild cognitive impairment. Twenty participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T1) and 1-month follow-up (T2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Neurofeedback, Electroencephalography, MCI, Alzheimer
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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMR neurofeedback training to MCI
Arm Type
Experimental
Arm Description
A sensorimotor/theta neurofeedback training consisted of 20 individuals sessions, twice a week during 11 weeks maximum. For each subject, NF was planned and conducted by a neuropsychologist experienced in neurophysiology an neurofeedback. Each session lasted 1h10 minutes and was conducted as follows:
Preparation and installation of the electrodes, verification of the impedance, adjustement of the calibration.
NF training (tasks and video described below)(45minutes)
Feedback and debriefing about the session (15 minutes)
Intervention Type
Behavioral
Intervention Name(s)
SMR neurofeedback training to MCI
Other Intervention Name(s)
SMR, neurofeedback
Intervention Description
The intervention consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta 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 (EEGDigitrcak Biofeedback plus module, Inc Elmiko Medical) was used for the SMR/theta Neurofeedback training.
Primary Outcome Measure Information:
Title
Rey Auditory Verbal Learning test
Description
Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.
Time Frame
Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Secondary Outcome Measure Information:
Title
Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
Description
Electroencephalography was recorded and EEG power spectrum was calculated using the fast Fourier transform. The power spectral density was calculated to extract the relative power for each frequency band and estimated as a log-ratio.
Time Frame
Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Mild Cognitive Impairment
education level of 9 years of studies minimum
righthandedness
subjective memory complaint confirmed by an informant
a Mini Mental Status Examination score >20.
preserve activity of daily living and absence of dementia.
Exclusion Criteria:
elderly persons who were under guardianship
resident in nursing facilities
neurological disease, psychiatric disease
and involved in another cogniitve intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anne-Sophie AR Rigaud, Professor
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment
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