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Trial record 2 of 155 for:    neurofeedback

Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment (Neurofeedel)

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ClinicalTrials.gov Identifier: NCT03855319
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Fabienne Marlats, Broca Hospital

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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: no randomized, no controlled
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 15, 2018

Arm Intervention/treatment
Experimental: SMR neurofeedback training to MCI

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)
Behavioral: SMR neurofeedback training to MCI
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.
Other Names:
  • SMR
  • neurofeedback




Primary Outcome Measures :
  1. Rey Auditory Verbal Learning test [ Time Frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up ]
    Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.


Secondary Outcome Measures :
  1. Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands. [ Time Frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up ]
    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.



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03855319


Sponsors and Collaborators
Fabienne Marlats
Investigators
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Principal Investigator: anne-Sophie AR Rigaud, Professor Study Principal Investigator

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Responsible Party: Fabienne Marlats, Neuropsychologist, Broca Hospital
ClinicalTrials.gov Identifier: NCT03855319     History of Changes
Other Study ID Numbers: LUS3EEGNF
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Electroencephalography
MCI
Alzheimer

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders