Feasibility Study of Neurofeedback Training for Older Adults With Mild Cognitive Impairment

NCT ID: NCT03686839

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2018-07-20

Brief Summary

This is a non-pharmacological study evaluating the feasibility of a neurofeedback training program in elderly with mild cognitive impairment (MCI) according to recruitment, retention, attendance, acceptability data.

Detailed Description

Neurofeedback (NF) can be counted amongst promising techniques to improve cognitive functioning if the principles of application are seriously respected, whilst recognizing the necessary adaptation to the conditions of patients with Mild Cognitive Impairment (MCI). This study examined the feasibility and acceptability of an electroencephalography neurofeedback training protocol in a sample group of older adults with MCI in order to identify the necessary conditions for an improved neurofeedback application. Participants performed an electroencephalography recording, a battery of neuropsychological tests before the neurofeedback training program (T0), following the neurofeedback training program (T2) and 1-month follow-up (T3). A questionnaire about motivation, opinions of technical aspects of NF and feeling of cognitive improvement was administered at T0 and T2.

Conditions

Mild Cognitive Impairment, So Stated

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SMR neurofeedback training to MCI

Sensorimotor rhythm neurofeedback protocol consisted of 20 individual sessions, twice a week, during 11 weeks maximum. For each subject MCI, NF was planned and conducted by a neuropsychologist experienced in neurophysiology and neurofeedback. Each session lasted 1h10-15min and was conducted as follows:

1. Preparation and installation of the electrodes, verification of the impedance, adjustment of the calibration and thresholds (15 minutes).

2. NF training (tasks and video described below) (45 minutes).

3. Feedback and debriefing about the session (15 minutes).

Group Type: EXPERIMENTAL

SMR neurofeedback training to MCI

Intervention Type: BEHAVIORAL

SMR neurofeedback training consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta ratio 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 (EEGDigitrack Biofeedback plus module, Inc Elmiko Medical) was used for SMR/theta neurofeedback training.

Interventions

SMR neurofeedback training to MCI

SMR neurofeedback training consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta ratio 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 (EEGDigitrack Biofeedback plus module, Inc Elmiko Medical) was used for SMR/theta neurofeedback training.

Intervention Type: BEHAVIORAL

Other Intervention Names

SMR

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Mild Cognitive Impairment
• Absence of history of alcohol or other substance consumption

Exclusion Criteria

• Psychiatric and neurological disorders
• sensory and/or motor deficit.
• involving in another cognitive intervention

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fabienne Marlats

OTHER

Sponsor Role: lead

Responsible Party

Fabienne Marlats

Neuropsychologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anne-Sophie AR Rigaud, Professor

Role: STUDY_DIRECTOR

Broca University Hospital

Locations

Anne-Sophie Rigaud

Paris, , France

Countries

France

Other Identifiers

LUS2EEGNF

Identifier Type: -

Identifier Source: org_study_id