NCT03526692

Brief Summary

This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Status
unknown

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

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

May 4, 2018

Last Update Submit

May 16, 2018

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairmentNeurofeedbackelectroencephalographyattentionmemory

Outcome Measures

Primary Outcomes (1)

  • Change on attention test, TMTB-TMA

    assessment of the Trail Making Test B and A, calculation of subtraction

    Baseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-up

Secondary Outcomes (1)

  • Change on Rey Auditory Verbal Learning Test

    Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention, and after 3-months follow-up

Study Arms (3)

Sensorimotor/delta NF training group

EXPERIMENTAL

Three interventions will be administered: * An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system.

Behavioral: Neurofeedback

Beta1/theta NF training group

EXPERIMENTAL

Three interventions will be administered: * An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system.

Behavioral: Neurofeedback

Control group

NO INTERVENTION

Three interventions will be administered: * An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions.

Interventions

NeurofeedbackBEHAVIORAL

Neurofeedback experiment will consist of 30 sessions of neurofeedback training, twice or three times a week during maximum 4 months. The two experimental groups will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-training (T1) and 3 months follow-up (T2). Electroencephalography will be recorded by a technician in EEGFor each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T2 and T3.

Also known as: Electroencephalography
Beta1/theta NF training groupSensorimotor/delta NF training group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Mild Cognitive Impairment
  • MMSE score \>24
  • Subjective memory complaint confirmed by an informant.
  • Perform at/or below 1.5 standard deviations from the mean for age and education-matched norms on more than one of the neuropsychological tests.
  • Preserve activity of daily living
  • Absence of dementia.

You may not qualify if:

  • Psychiatric and neurological disorders
  • History of alcohol or other substance consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Marlats F, Bao G, Chevallier S, Boubaya M, Djabelkhir-Jemmi L, Wu YH, Lenoir H, Rigaud AS, Azabou E. SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Front Aging Neurosci. 2020 Jun 16;12:147. doi: 10.3389/fnagi.2020.00147. eCollection 2020.

    PMID: 32612522DERIVED

  • Marlats F, Djabelkhir-Jemmi L, Azabou E, Boubaya M, Pouwels S, Rigaud AS. Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial. Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.

    PMID: 30696475DERIVED

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

    Broca University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie AR Rigaud, professor

CONTACT

0033144083503anne-sophie.rigaud@brc.aphp.fr

Fabienne FM Marlats, PhD candidate

CONTACT

0033622311862fabiennemarlats@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparison between three groups : two experimental groups and a control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share