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

NCT04027725 | Unknown

• 2 other identifiers: K170908J2017-A02933-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive Impairment; Neurofeedback; Electroencephalography; Memory; Attention

Outcome Measures

Primary Outcomes (1)

• Change on Rey Auditory Verbal Learning test

  Assessment of Verbal learning in episodic memory

  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 Outcomes (1)

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

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

Study Arms (2)

Sensorimotor neurofeedback training group

EXPERIMENTAL

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.

Behavioral: Neurofeedback

Control Group

NO INTERVENTION

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

Interventions

Neurofeedback 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.

Also known as: Electroencephalography

Sensorimotor neurofeedback training group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital BROCA

Paris, 75013, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Anne-Sophie RIGAUD, Professor

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie RIGAUD, Professor

CONTACT

00331440835; anne-sophie.rigaud@aphp.fr

Fabienne MARLATS, Doctor

CONTACT

0033622311862; fabiennemarlats@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)