Mild Cognitive Impairment, So StatedNeurofeedelNCT03686839
Feasibility Study of Neurofeedback Training for Older Adults With Mild Cognitive Impairment
A study testing SMR neurofeedback training to MCI in people with Mild Cognitive Impairment, So Stated, run by Fabienne Marlats at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, So Stated
- What is being tested?
- SMR neurofeedback training to MCI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2017to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Mild Cognitive Impairment
- Absence of history of alcohol or other substance consumption
Who cannot join
- Psychiatric and neurological disorders
- sensory and/or motor deficit.
- involving in another cognitive intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment
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.
Read the 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
- Being tested
- SMR neurofeedback training to MCI
- Keywords
- Neurofeedback, Acceptance technology, Electroencephalography, MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMR neurofeedback training to MCIBehavioural
Also called SMR
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.
| Study group | Role | What they receive |
|---|---|---|
| SMR neurofeedback training to MCI | Experimental | 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). Receives: Behavioral: SMR neurofeedback training to MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback Technology Acceptation Questionnaire
Neurofeedback Technology Acceptation Questionnaire assessed the participants' opinions face to the electroencephalography neurofeedback intervention with 33 questions. The mode of administration was a personal interview with the investigator, the type of questions was closed-ended (for binary variable yes or no). Answers were analyzed with the Multiple Correspondence Analysis to visualize associations and similarities among participants and answers to Questionnaire. An unsupervised hierarchical clustering was performed using the Euclidean distance and Ward's method. Clusters were defined graphically using dendrogram.
Measured: Assessment was at 2 months immediately after the Neurofeedback intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start3 Mar 2017
- Primary completion18 Jun 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment, So StatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- no randomized, no controlled.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabienne Marlats
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabienne Marlats, Broca Hospital
- Investigators
- Anne-Sophie AR Rigaud, Professor, Study director, Broca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686839
- Sponsor's protocol ID
- LUS2EEGNF
- Acronym
- Neurofeedel
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Exploring Feasibility and Acceptability in Application of EEG Neurofeedback in Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03686839
- Acronym / sponsor ID
- Neurofeedel / LUS2EEGNF
- Conditions
- Mild Cognitive Impairment, So Stated
- Keywords
- Neurofeedback, Acceptance technology, Electroencephalography, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fabienne MarlatsUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- no randomized, no controlled.
| Arm | Type | Receives |
|---|---|---|
| SMR neurofeedback training to MCI | Experimental | Behavioral: SMR neurofeedback training to MCISensorimotor 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Mild Cognitive Impairment
- Absence of history of alcohol or other substance consumption
Key exclusion criteria (3 listed)
- Psychiatric and neurological disorders
- sensory and/or motor deficit.
- involving in another cognitive intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMR neurofeedback training to MCIAlso: SMRSMR 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. | Behavioural | SMR neurofeedback training to MCI |
Primary outcome
Neurofeedback Technology Acceptation Questionnaire
Time frame: Assessment was at 2 months immediately after the Neurofeedback intervention
Neurofeedback Technology Acceptation Questionnaire assessed the participants' opinions face to the electroencephalography neurofeedback intervention with 33 questions. The mode of administration was a personal interview with the investigator, the type of questions was closed-ended (for binary variable yes or no). Answers were analyzed with the Multiple Correspondence Analysis to visualize associations and similarities among participants and answers to Questionnaire. An unsupervised hierarchical clustering was performed using the Euclidean distance and Ward's method. Clusters were defined graphically using dendrogram.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie AR Rigaud, Professor study director
Broca University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMR neurofeedback training to MCI in people with Mild Cognitive Impairment, So Stated, run by Fabienne Marlats at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofeedback Technology Acceptation Questionnaire (time frame: Assessment was at 2 months immediately after the Neurofeedback intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.