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

Mild Cognitive Impairment Clinical Trial

— NEUROFEEDEL  

Official title:

Pilot Study Evaluating the Effectiveness of Neurofeedback Training in the Improvement of Cognitive Functions of the Elderly With Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04027725
• Other study ID #: K170908J
• Secondary ID: 2017-A02933-50
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: November 2021

Study information

• Verified date: October 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anne-Sophie RIGAUD, Professor
• Phone: 00331440835
• Email: anne-sophie.rigaud[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Hopital BROCA	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	assessment at baseline, change from baseline to immediately after the NF training and 1 month follow-up