Mild Cognitive ImpairmentNCT03526692
Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study
A study testing Neurofeedback in people with Mild Cognitive Impairment, run by Fabienne Marlats.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Feb 2020
- 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
- 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.
Who cannot join
- Psychiatric and neurological disorders
- History of alcohol or other substance consumption
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Neurofeedback
- Keywords
- Mild cognitive impairment, Neurofeedback, electroencephalography, attention, memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
Also called Electroencephalography
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor/delta NF training group | Experimental | Three interventions will be administered:
* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.
* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.
* The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system. Receives: Behavioral: Neurofeedback |
| Beta1/theta NF training group | Experimental | Three interventions will be administered:
* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.
* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.
* The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system. Receives: Behavioral: Neurofeedback |
| Control group | No intervention | Three interventions will be administered: * An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on attention test, TMTB-TMA
assessment of the Trail Making Test B and A, calculation of subtraction
Measured: 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 outcomes (1)
Change on Rey Auditory Verbal Learning Test
Assessment of verbal learning in episodic memory
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between three groups : two experimental groups and a control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, Broca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526692
- Sponsor's protocol ID
- LUS1EEGNF
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marlats F, Bao G, Chevallier S, Boubaya M, Djabelkhir-Jemmi L, Wu YH, Lenoir H, Rigaud AS, Azabou E. SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Front Aging Neurosci. 2020 Jun 16;12:147. doi: 10.3389/fnagi.2020.00147. eCollection 2020.
PubMed 32612522Marlats F, Djabelkhir-Jemmi L, Azabou E, Boubaya M, Pouwels S, Rigaud AS. Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial. Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.
PubMed 30696475
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03526692
- Acronym / sponsor ID
- LUS1EEGNF
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Neurofeedback, electroencephalography, attention, memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fabienne MarlatsUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 16 May 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 effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison between three groups : two experimental groups and a control group
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor/delta NF training group | Experimental | Behavioral: NeurofeedbackThree interventions will be administered: * An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system. |
| Beta1/theta NF training group | Experimental | Behavioral: NeurofeedbackThree interventions will be administered: * An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system. |
| Control group | No intervention | –Three interventions will be administered: * An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. * The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. * The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Psychiatric and neurological disorders
- History of alcohol or other substance consumption
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 |
|---|---|---|
| NeurofeedbackAlso: ElectroencephalographyNeurofeedback 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. | Behavioural | Beta1/theta NF training group, Sensorimotor/delta NF training group |
Primary outcome
Change on attention test, TMTB-TMA
Time frame: 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
assessment of the Trail Making Test B and A, calculation of subtraction
1 secondary outcome
Change on Rey Auditory Verbal Learning Test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Derived from this study: PubMed 32612522Marlats F, Bao G, Chevallier S, Boubaya M, Djabelkhir-Jemmi L, Wu YH, Lenoir H, Rigaud AS, Azabou E. SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Front Aging Neurosci. 2020 Jun 16;12:147. doi: 10.3389/fnagi.2020.00147. eCollection 2020.
- Derived from this study: PubMed 30696475Marlats F, Djabelkhir-Jemmi L, Azabou E, Boubaya M, Pouwels S, Rigaud AS. Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial. Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.
- 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
Broca University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback 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 2 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: status not confirmed, as of the sponsor's last update on 18 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie AR Rigaud, professor (0033144083503, anne-sophie.rigaud@brc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on attention test, TMTB-TMA (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526692, which also lists 2 linked publications.
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 18 May 2018.