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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03855319
Other study ID # LUS3EEGNF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date December 15, 2018

Study information

Verified date February 2019
Source Broca Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a non-pharmacological pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.


Description:

Neurofeedback training (NF) as self-regulation method of brain activity, may be beneficial in elderly with mild cognitive impairment. In this pilot study, the investigators studied whether a sensorimotor(SMR)/theta NF training could improve cognitive performance and brain electrical activity in a sample group of elderly patients with mild cognitive impairment. Twenty participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T1) and 1-month follow-up (T2).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 15, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Mild Cognitive Impairment

- education 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 cogniitve intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMR neurofeedback training to MCI
The intervention consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta training was recorded at channel Cz according to the international 10-20 system. Theta rhythm was also recorded and, in this case, SMR was stimulated while theta waves were suppressed.A 32 channels system (EEGDigitrcak Biofeedback plus module, Inc Elmiko Medical) was used for the SMR/theta Neurofeedback training.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fabienne Marlats

Outcome

Type Measure Description Time frame Safety issue
Primary Rey Auditory Verbal Learning test Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process. Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Secondary Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands. 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 11 weeks immediately after the NF training and 1 month follow-up
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