Mild Cognitive ImpairmentNeurofeedelNCT03855319
Neurofeedback Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment
A study testing SMR neurofeedback training to MCI in people with Mild Cognitive Impairment, run by Fabienne Marlats.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 15 Dec 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- elderly persons who were under guardianship
- resident in nursing facilities
- neurological disease, psychiatric disease
- and involved in another cogniitve intervention.
About this study
Official title: SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study
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.
Read the detailed 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).
- Conditions
- Mild Cognitive Impairment
- Being tested
- SMR neurofeedback training to MCI
- Keywords
- Neurofeedback, Electroencephalography, MCI, Alzheimer
- 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, neurofeedback
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.
| Study group | Role | What they receive |
|---|---|---|
| SMR neurofeedback training to MCI | Experimental | A sensorimotor/theta neurofeedback training consisted of 20 individuals sessions, twice a week during 11 weeks maximum. For each subject, NF was planned and conducted by a neuropsychologist experienced in neurophysiology an neurofeedback. Each session lasted 1h10 minutes and was conducted as follows:
* Preparation and installation of the electrodes, verification of the impedance, adjustement of the calibration.
* NF training (tasks and video described below)(45minutes)
* 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.
Rey Auditory Verbal Learning test
Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.
Measured: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Secondary outcomes (1)
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.
Measured: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start15 Dec 2016
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 20 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, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855319
- Sponsor's protocol ID
- LUS3EEGNF
- Acronym
- Neurofeedel
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 28 Feb 2019
- 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 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study
- ClinicalTrials.gov ID
- NCT03855319
- Acronym / sponsor ID
- Neurofeedel / LUS3EEGNF
- Conditions
- Mild Cognitive Impairment
- Keywords
- Neurofeedback, Electroencephalography, MCI, Alzheimer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fabienne MarlatsUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 26 Feb 2019 (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 pilot study showing the improvement of a SMR/theta neurofeedback training program on cognitive performance and EEG activity in Elderly with Mild Cognitive Impairment.
Detailed 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).
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 MCIA sensorimotor/theta neurofeedback training consisted of 20 individuals sessions, twice a week during 11 weeks maximum. For each subject, NF was planned and conducted by a neuropsychologist experienced in neurophysiology an neurofeedback. Each session lasted 1h10 minutes and was conducted as follows: * Preparation and installation of the electrodes, verification of the impedance, adjustement of the calibration. * NF training (tasks and video described below)(45minutes) * Feedback and debriefing about the session (15 minutes) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- elderly persons who were under guardianship
- resident in nursing facilities
- neurological disease, psychiatric disease
- and involved in another cogniitve 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: SMR, neurofeedbackThe 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. | Behavioural | SMR neurofeedback training to MCI |
Primary outcome
Rey Auditory Verbal Learning test
Time frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
Assessment of verbal learning in episodic memory, evaluating the ability to encode, combine, store and long-term consolidation process.
1 secondary outcome
Relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.
Time frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up
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 28 Feb 2019.
- Individual participant dataSharing planned: No
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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 principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
A study testing SMR neurofeedback training to MCI in people with Mild Cognitive Impairment, run by Fabienne Marlats.
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 6 inclusion and 4 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Rey Auditory Verbal Learning test (time frame: Assessment at baseline, change from baseline to 11 weeks immediately after the NF training and 1 month follow-up). 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 28 Feb 2019.