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NEUROFEEDBACK TRAINING FOR OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT: A PILOT STUDY (NEUROFEEDEL)

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild cognitive Impairment, Neurofeedback, Electroencephalography, Memory, Attention

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of Mild Cognitive Impairment, educational 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 cognitive intervention.

Sites / Locations

  • Hopital BROCA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sensorimotor neurofeedback training group

Control Group

Arm Description

Three interventions will be administered : An electroencephalography recording (EEG) for 30 minutes with 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 2hours. The third intervention is the neurofeedback training sensorimotor that will be recorded at channel Cz according to the international 10-20 system.

Three interventions will be administered : An electroencephalography recording (EEG) for 30 minutes with 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 2hours The psychopedagogical care: each session will be organized using the same video material

Outcomes

Primary Outcome Measures

Change on Rey Auditory Verbal Learning test
Assessment of Verbal learning in episodic memory

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2019
Last Updated
October 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04027725
Brief Title
NEUROFEEDBACK TRAINING FOR OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT: A PILOT STUDY
Acronym
NEUROFEEDEL
Official Title
Pilot Study Evaluating the Effectiveness of Neurofeedback Training in the Improvement of Cognitive Functions of the Elderly With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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
The purpose of this study is to evaluate the effects of SMR neurofeedback training on cognitive performance and electrical brain activity in elderly with cognitive impairment.
Detailed Description
Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents on of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. The investigators aim to study the effects of a sensorimotor neurofeedback training protocol (SMR) on cognitive performances in elderly and to assess whether MCI patients change in brain electrical activity after training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive Impairment, Neurofeedback, Electroencephalography, Memory, Attention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensorimotor neurofeedback training group
Arm Type
Experimental
Arm Description
Three interventions will be administered : An electroencephalography recording (EEG) for 30 minutes with 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 2hours. The third intervention is the neurofeedback training sensorimotor that will be recorded at channel Cz according to the international 10-20 system.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Three interventions will be administered : An electroencephalography recording (EEG) for 30 minutes with 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 2hours The psychopedagogical care: each session will be organized using the same video material
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
Electroencephalography
Intervention Description
Neurofeedback experiment will consist of 20 sessions of neurofeedback training, twice or three times a week during seven weeks. Each session will last for 40 minutes. The experimental group will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-trianing (T1) and 1 month follow-up (T2). Electroencephalography will be recorded by a technician in EEG for each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T1 and T2.
Primary Outcome Measure Information:
Title
Change on Rey Auditory Verbal Learning test
Description
Assessment of Verbal learning in episodic memory
Time Frame
Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention , and after 1-month follow-up
Secondary Outcome Measure Information:
Title
relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
Description
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 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, educational 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 cognitive intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie RIGAUD, Professor
Phone
00331440835
Email
anne-sophie.rigaud@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabienne MARLATS, Doctor
Phone
0033622311862
Email
fabiennemarlats@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie RIGAUD, Professor
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital BROCA
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie RIGAUD, Professor
Phone
00331440835
Email
anne-sophie.rigaud@aphp.fr
First Name & Middle Initial & Last Name & Degree
Fabienne MARLATS, Doctor
Phone
0033622311862
Email
fabiennemarlats@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NEUROFEEDBACK TRAINING FOR OLDER ADULTS WITH MILD COGNITIVE IMPAIRMENT: A PILOT STUDY

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