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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03447236 |
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Date of registration:
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18/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Functional MRI Changes Resulting From the Feuerstein Program in Older People With Mild Cognitive Impairment (MCI)
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Scientific title:
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An Evaluation of Changes in Brain Functional Connectivity Resulting From Cognitive Intervention by Means of the Feuerstein Instrumental Enrichment Program in Older People With Mild Cognitive Impairment (MCI) |
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Date of first enrolment:
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July 4, 2017 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03447236 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Tzvi Dwolatzky, MD MBBCh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Aged 60 and above.
2. Hebrew speakers.
3. Expressing willingness to participate in the research and deliberately signing a
consent form.
4. A diagnosis of MCI exists according to accepted clinical criteria - the examinee's
score in the MoCA Test is within the range of 18-26 (inclusive).
Exclusion Criteria:
1. A medical or functional condition that will not allow the subject to participate in
the intervention program within the research period.
2. Diagnosed subjects suffering from active depression, bipolar disorder or
schizophrenia.
3. Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium
dementia or mental retardation).
4. Visual impairment that will not allow subjects to observe detailed information on a
32' screen from a distance of 1 meter.
5. Hearing impairment that will not allow subjects to listen to instructions during
assessment.
6. Subjects whose MoCA Test's score is 17 and below or 27 and above.
7. Subjects unable to undergo MRI assessments based on a standard questionnaire of
eligibility for MRI excluding the use of metal and electronic implants.
8. Subjects who will decide not to participate following a 10 minute MRI scan which will
allow subjects to experience the procedure.
9. The finding of a Random Space Occupying Lesion on MRI scan at initial anatomical
assessment.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mild Cognitive Impairment
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Intervention(s)
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Behavioral: Feuerstein Program
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Primary Outcome(s)
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Change from baseline functional connectivity
[Time Frame: Through study completion, an average of 11 months]
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Secondary Outcome(s)
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Change from baseline cognitive function
[Time Frame: Through study completion, an average of 11 months]
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Secondary ID(s)
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0580-16-RMB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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