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Mild Cognitive ImpairmentNCT02388451

The Benefits of the Use of the Feuerstein Cognitive Training Method on Cognitive Function in Community-dwelling Older Patients With Mild Cognitive Impairment: a Pilot Study

A study testing Feuerstein Program in people with Mild Cognitive Impairment, run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Feuerstein Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteIsrael
Study dates
Dec 2015to Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65 years and older
  • Able to read and speak Hebrew
  • Provide informed consent for participation in the study
  • Clinical diagnosis of MCI based on Consensus Criteria
  • A score of lower than 95 on the Memory Index of the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery

Who cannot join

  • A medical condition (such as advanced heart failure, unstable ischemic heart disease, a lung condition with dyspnea on mild effort, intractable pain) or functional impairment (especially limiting mobility without the home) that does not allow the subject to participate in the training activities for the full duration of the study
  • A diagnosis of depression, bipolar disorder or schizophrenia
  • A cognitive diagnosis other than MCI, such as delirium, dementia or mental retardation
  • Visual impairment not corrected by the use of spectacles
  • Hearing impairment not corrected by hearing aids

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Yan Press

    Beersheba

Other trials in Israel

About this study

15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.

Read the detailed description

The rise in life expectancy in recent decades has resulted in a dramatic increase in the population of older people. This has been associated with a rise in the prevalence of age-associated conditions, particularly cognitive impairment and dementia. The prevalence of dementia in those older than 65 doubles every five years, and reaches a rate of more than 40% at age 85 years. Data from the World Health Organization predict 43 million dementia sufferers globally in the year 2020.

Mild Cognitive Impairment (MCI) is a syndrome comprising cognitive symptoms and impairment beyond population norms based on age and education, without functional loss. MCI represents a risk factor for dementia at a rate of conversion of approximately 12% annually. Thus patients with MCI characterize an important group for possible interventions in preventing further cognitive decline, particularly physical exercise and cognitive training.

The Feuerstein Program The Feuerstein Instrumental Enrichment (IE) program has been well-established as an effective intervention in other age groups and clinical situations. The method's creator, Professor Reuven Feuerstein, postulated that the thinking process is divided into three major phases - Input, Elaboration and Output - and that in each phase, different mental functions are at work. The quality of thinking depends upon the way the different functions are activated in each of the phases. The IE tools enable the correction or activation of cognitive deficiencies through use of targeted and focused mediation, which conserves and reinforces cognitive ability.

Recently, the Feuerstein Instrumental Enrichment Program for the Elderly was developed particularly for older people with cognitive decline.

Instrumental Enrichment can benefit all senior citizens, but is particularly recommended for those who do not constantly face intellectual challenges.

The process of learning IE is administered in group settings by instructors who have been trained to specifically mediate to the geriatric population. Work in groups constitutes a challenging, interesting and gratifying activity. It also appears that beyond contributing to the conservation and improvement of cognition, participating in the program may also have the effect of increasing feelings of competence, independence and improved emotional state.

15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.

Being tested
Feuerstein Program
Keywords
Mild Cognitive Impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feuerstein ProgramDevice

    The IE activity is administered by instructors in groups of 10 to 15 participants. The intervention comprises 30 twice weekly meetings of 90 minutes duration per group.

Study groups in NCT02388451
Study groupRoleWhat they receive
Feuerstein ProgramExperimental15 subjects conforming to inclusion and exclusion criteria with a known clinical diagnosis of MCI and who provide informed consent will undergo cognitive and functional assessment to confirm the diagnosis of MCI. Baseline assessment using the Mindstreams Mild Cognitive Impairment Computerized Assessment Battery will be performed. Subjects will then participate 30 twice weekly meetings of 90 minutes duration each (for a total of 15 weeks). Mindstreams testing will be repeated after 15 sessions and at completion of the study.
Receives: Device: Feuerstein Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mindstreams Mild Cognitive Impairment Computerized Assessment Battery

    The Mindstreams Mild Cognitive Impairment Computerized Assessment Battery developed by Neurotrax Corp. provides index scores in multiple cognitive domains, as well as a Global cognitive score

    Measured: Change from Baseline Cognitive Function at 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2017
  4. Study completionAug 2018

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388451
Sponsor's protocol ID
001
Status last verified
Jan 2019
First submitted
26 Feb 2015
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Feuerstein Program in people with Mild Cognitive Impairment, run by Meir Medical Center at 1 site in Israel.

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 5 inclusion and 5 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 23 Jan 2019. 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 Israel. 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?

Mindstreams Mild Cognitive Impairment Computerized Assessment Battery (time frame: Change from Baseline Cognitive Function at 15 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 23 Jan 2019.

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