Mild Cognitive ImpairmentNCT03375151
An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
A study testing EEG based feedback, Standard practice based feedback and No feedback in people with Mild Cognitive Impairment, run by Brainmarc Ltd..
Trial summary
The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral… Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- EEG based feedback, Standard practice based feedback and No feedback
- Type of treatment
- Medical device, 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
- Feb 2018to Apr 2019
- 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 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female above the age of 65 years
- Ability to read, write and understand the Hebrew language so to comply with study demands.
- Diagnosed with Amnestic MCI. Mini Mental State Examination (MMSE), A score of MSSE ≥27 for college educated subjects and MSSE ≥ 26 for all others; and (CDR) Clinical Dementia Rating, 0.5 ≥ CDR
- Diagnosed with memory impairment, Visual Paired Association = VPA (WMS-R), for subjects of ages 65-70, 16.5 ≥ WMS-R and for subjects of age above 71, 15.5 ≥ WMS-R
Who cannot join
- Diagnosed with major psychiatric or neurological disorder.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
Trial locations and contacts
No sites are listed yet.
About this study
The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral recommendations for physical exercise. Some recommendations could also be found for cognitive practice. However, currently, there is no consensus regarding effective cognitive treatment or practice for MCI. Among the populations suffering from MCI, there is a significant segment of patients with amnestic disorder. For these patients, it seems that cognitive training of memory, including verbal memory, is very important. In recent years, we have developed an effective tool for managing rehabilitation practice by monitoring the patient's engagement with an easy-to-use EEG (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when the patient is recruited, the clinical improvement is significantly better. The aim of this study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve functional improvement in verbal memory training in patients with Amnestic MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- EEG based feedback, Standard practice based feedback, No feedback
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG based feedbackDevice
Participants will participate in cognitive training sessions. The therapist will use feedback from the EEG analyzed data to direct the cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise.
Standard practice based feedbackBehavioural
Participants will participate in cognitive training sessions. The therapist will give feedback to the participants during the exercise based on their performance only according to the his therapist standard practice.
No feedbackBehavioural
Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.
| Study group | Role | What they receive |
|---|---|---|
| EEG based feedback | Experimental | The therapist will give feedback to the participants during the exercise based on their performance.and use the feedback from the EEG analyzed data to direct cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise. Receives: Device: EEG based feedback; Behavioral: Standard practice based feedback |
| Standard practice based feedback | Other | The therapist will give feedback to the participants during the exercise based on their performance. Receives: Behavioral: Standard practice based feedback |
| No feedback | Other | The participants will perform the exercise without feedback during practice. Receives: Behavioral: No feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive test grade
The difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.
Measured: up to 5 weeks
Secondary outcomes (4)
Rey Auditory-Verbal Learning Test
The difference in grades of Free And Cued Selective Reminding Test (FCSRT) score between the beginning and the end of the study.
Measured: up to 5 weeks
Free And Cued Selective Reminding Test
The difference in grades of Rey Auditory-Verbal Learning Test (RAVLT) score between the beginning and the end of the study.
Measured: up to 5 weeks
Rivermead Behavioral Memory Test
The difference in grades of Rivermead Behavioral Memory Test (RBMT) score between the beginning and the end of the study.
Measured: up to 5 weeks
Clinical Global Impression of Change
The difference in grades of Clinical Global Impression of Change (CGI-C) score between the beginning and the end of the study.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study startFeb 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionApr 2019 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainmarc Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Dvir, Dr., Principal investigator, Reuth rehabilitation medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375151
- Sponsor's protocol ID
- CLD13
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03375151
- Acronym / sponsor ID
- CLD13
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brainmarc Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 15 Dec 2017 (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.
The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral recommendations for physical exercise. Some recommendations could also be found for cognitive practice. However, currently, there is no consensus regarding effective cognitive treatment or practice for MCI. Among the populations suffering from MCI, there is a significant segment of patients with amnestic disorder. For these patients, it seems that cognitive training of memory, including verbal memory, is very important. In recent years, we have developed an effective tool for managing rehabilitation practice by monitoring the patient's engagement with an easy-to-use EEG (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when the patient is recruited, the clinical improvement is significantly better. The aim of this study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve functional improvement in verbal memory training in patients with Amnestic MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EEG based feedback | Experimental | Device: EEG based feedback, Behavioral: Standard practice based feedbackThe therapist will give feedback to the participants during the exercise based on their performance.and use the feedback from the EEG analyzed data to direct cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise. |
| Standard practice based feedback | Other | Behavioral: Standard practice based feedbackThe therapist will give feedback to the participants during the exercise based on their performance. |
| No feedback | Other | Behavioral: No feedbackThe participants will perform the exercise without feedback during practice. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male or female above the age of 65 years
- Ability to read, write and understand the Hebrew language so to comply with study demands.
- Diagnosed with Amnestic MCI. Mini Mental State Examination (MMSE), A score of MSSE ≥27 for college educated subjects and MSSE ≥ 26 for all others; and (CDR) Clinical Dementia Rating, 0.5 ≥ CDR
- Diagnosed with memory impairment, Visual Paired Association = VPA (WMS-R), for subjects of ages 65-70, 16.5 ≥ WMS-R and for subjects of age above 71, 15.5 ≥ WMS-R
Key exclusion criteria (2 listed)
- Diagnosed with major psychiatric or neurological disorder.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
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 |
|---|---|---|
| EEG based feedbackParticipants will participate in cognitive training sessions. The therapist will use feedback from the EEG analyzed data to direct the cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise. | Device | EEG based feedback |
| Standard practice based feedbackParticipants will participate in cognitive training sessions. The therapist will give feedback to the participants during the exercise based on their performance only according to the his therapist standard practice. | Behavioural | EEG based feedback, Standard practice based feedback |
| No feedbackParticipants will participate in cognitive training sessions. The therapist will not guide them during the sessions. | Behavioural | No feedback |
Primary outcome
Cognitive test grade
Time frame: up to 5 weeks
The difference in grades in a test for evaluation cognitive abilities in a textual assignment between the beginning and the end of the study.
4 secondary outcomes
Rey Auditory-Verbal Learning Test
Time frame: up to 5 weeks
Free And Cued Selective Reminding Test
Time frame: up to 5 weeks
Rivermead Behavioral Memory Test
Time frame: up to 5 weeks
Clinical Global Impression of Change
Time frame: up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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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.
David Dvir, Dr. principal investigator
Reuth rehabilitation medical center
Questions about this trial
What is this clinical trial studying?
A study testing EEG based feedback, Standard practice based feedback and No feedback in people with Mild Cognitive Impairment, run by Brainmarc Ltd..
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 4 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 15 Dec 2017. 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 Goded Shahaf, Dr. (97246660676, goded@brainmarc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive test grade (time frame: up to 5 weeks). 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 15 Dec 2017.