NCT03855319

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

February 25, 2019

Last Update Submit

February 26, 2019

Conditions

Keywords

NeurofeedbackElectroencephalographyMCIAlzheimer

Outcome Measures

Primary Outcomes (1)

  • Rey Auditory Verbal Learning test

    Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.

    Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

Secondary Outcomes (1)

  • Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.

    Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up

Study Arms (1)

SMR neurofeedback training to MCI

EXPERIMENTAL

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

Interventions

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.

Also known as: SMR, neurofeedback
SMR neurofeedback training to MCI

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • elderly persons who were under guardianship
  • resident in nursing facilities
  • neurological disease, psychiatric disease
  • and involved in another cogniitve intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • anne-Sophie AR Rigaud, Professor

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: no randomized, no controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neuropsychologist

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 26, 2019

Study Start

December 15, 2016

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share