Mild Cognitive Impairment Clinical Trial
Official title:
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)
NCT number | NCT03447236 |
Other study ID # | 0580-16-RMB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 4, 2017 |
Est. completion date | June 28, 2019 |
Verified date | September 2019 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: The Feuerstein Instrumental Enrichment Program was designed to prevent mental
deterioration and preserve cognitive abilities among people aged 60 and above. The program is
an applied practicable program based on the theories of Structural Cognitive Modifiability as
well as on a Mediated Learning Experience. The program takes into consideration the unique
characteristics and requirements of the older population. The program is composed of a
variety of cognitive tasks that offer systematic activities intended to stimulate mental and
cognitive development.
Objective: To examine the influence of the Feuerstein Program on brain functional
connectivity as measured by MRI assessments and cognitive function of participants suffering
from Mild Cognitive Impairment (MCI).
Hypothesis: The Feuerstein Program will improve cognitive abilities and affect brain
functional connectivity.
Methods: Residents of retirement homes will be offered to participate in the study.
Participants will undergo cognitive and MRI assessments prior to and following a period of
cognitive intervention using the Feuerstein Instrumental Enrichment Program.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 28, 2019 |
Est. primary completion date | June 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Adolf und Mary Mil-Stiftung, Helen Bader Foundation, Montreal Jewish Community Fund, Rochlin Family Foundation |
Israel,
Allan TW, Francis ST, Caballero-Gaudes C, Morris PG, Liddle EB, Liddle PF, Brookes MJ, Gowland PA. Functional Connectivity in MRI Is Driven by Spontaneous BOLD Events. PLoS One. 2015 Apr 29;10(4):e0124577. doi: 10.1371/journal.pone.0124577. eCollection 2015. — View Citation
Deng Y, Liu K, Shi L, Lei Y, Liang P, Li K, Chu WC, Wang D; Alzheimer's Disease Neuroimaging Initiative. Identifying the Alteration Patterns of Brain Functional Connectivity in Progressive Mild Cognitive Impairment Patients: A Longitudinal Whole-Brain Voxel-Wise Degree Analysis. Front Aging Neurosci. 2016 Aug 17;8:195. doi: 10.3389/fnagi.2016.00195. eCollection 2016. — View Citation
Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. — View Citation
Esposito R, Mosca A, Pieramico V, Cieri F, Cera N, Sensi SL. Characterization of resting state activity in MCI individuals. PeerJ. 2013 Aug 20;1:e135. doi: 10.7717/peerj.135. eCollection 2013. — View Citation
Eyre HA, Acevedo B, Yang H, Siddarth P, Van Dyk K, Ercoli L, Leaver AM, Cyr NS, Narr K, Baune BT, Khalsa DS, Lavretsky H. Changes in Neural Connectivity and Memory Following a Yoga Intervention for Older Adults: A Pilot Study. J Alzheimers Dis. 2016;52(2):673-84. doi: 10.3233/JAD-150653. — View Citation
Hostage CA, Choudhury KR, Murali Doraiswamy P, Petrella JR; Alzheimer's Disease Neuroimaging Initiative. Mapping the effect of the apolipoprotein E genotype on 4-year atrophy rates in an Alzheimer disease-related brain network. Radiology. 2014 Apr;271(1):211-9. doi: 10.1148/radiol.13131041. Epub 2013 Dec 12. — View Citation
Karahanoglu FI, Van De Ville D. Transient brain activity disentangles fMRI resting-state dynamics in terms of spatially and temporally overlapping networks. Nat Commun. 2015 Jul 16;6:7751. doi: 10.1038/ncomms8751. — View Citation
Li Y, Wang X, Li Y, Sun Y, Sheng C, Li H, Li X, Yu Y, Chen G, Hu X, Jing B, Wang D, Li K, Jessen F, Xia M, Han Y. Abnormal Resting-State Functional Connectivity Strength in Mild Cognitive Impairment and Its Conversion to Alzheimer's Disease. Neural Plast. 2016;2016:4680972. doi: 10.1155/2016/4680972. Epub 2015 Dec 30. — View Citation
Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047. — View Citation
Meskaldji DE, Preti MG, Bolton TA, Montandon ML, Rodriguez C, Morgenthaler S, Giannakopoulos P, Haller S, Van De Ville D. Prediction of long-term memory scores in MCI based on resting-state fMRI. Neuroimage Clin. 2016 Oct 11;12:785-795. eCollection 2016. — View Citation
Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. Review. — View Citation
Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline functional connectivity | Based on correlation coefficient of FMRI signal between brain regions | Through study completion, an average of 11 months | |
Secondary | Change from baseline cognitive function | Based on Neurotrax computerized neuropsychological assessment battery | Through study completion, an average of 11 months |
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