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

NCT ID: NCT04027725

Last Updated: 2019-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sensorimotor neurofeedback training group

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.

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurofeedback

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Electroencephalography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne-Sophie RIGAUD, Professor

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital BROCA

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne-Sophie RIGAUD, Professor

Role: CONTACT

00331440835

Fabienne MARLATS, Doctor

Role: CONTACT

0033622311862

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne-Sophie RIGAUD, Professor

Role: primary

00331440835

Fabienne MARLATS, Doctor

Role: backup

0033622311862

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A02933-50

Identifier Type: OTHER

Identifier Source: secondary_id

K170908J

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurofeedback in Alzheimer's Disease
NCT03790774 TERMINATED NA