Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study

Mild Cognitive Impairment Clinical Trial

Official title:

Comparison of Effects Between SMR/Delta Ratio and beta1/Theta Ratio Neurofeedback Trainings for Older Adults With Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03526692
• Other study ID #: LUS1EEGNF
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: February 2020

Study information

• Verified date: May 2018
• Source: Broca Hospital
• Contact: Anne-Sophie AR Rigaud, professor
• Phone: 0033144083503
• Email: anne-sophie.rigaud[@]brc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 one 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. We aim to study the effects of two neurofeedback training protocols, SMR/delta ratio and beta1/theta ratio, on cognitive performances in older adults with Mild Cognitive Impairment and to assess whether MCI patients change in brain electrical activity in a resting state after training.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Psychiatric and neurological disorders

• History of alcohol or other substance consumption

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Neurofeedback
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fabienne Marlats

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 3-months follow-up