Mild Cognitive ImpairmentNCT03447236
Functional MRI Changes Resulting From the Feuerstein Program in Older People With Mild Cognitive Impairment (MCI)
A study testing Feuerstein Program in people with Mild Cognitive Impairment, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
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… 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?
- Feuerstein Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jul 2017to 28 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 and above.
- Hebrew speakers.
- Expressing willingness to participate in the research and deliberately signing a consent form.
- 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).
Who cannot join
- A medical or functional condition that will not allow the subject to participate in the intervention program within the research period.
- Diagnosed subjects suffering from active depression, bipolar disorder or schizophrenia.
- Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
- Visual impairment that will not allow subjects to observe detailed information on a 32' screen from a distance of 1 meter.
- Hearing impairment that will not allow subjects to listen to instructions during assessment.
- Subjects whose MoCA Test's score is 17 and below or 27 and above.
Show all 9Show fewer
- Subjects unable to undergo MRI assessments based on a standard questionnaire of eligibility for MRI excluding the use of metal and electronic implants.
- Subjects who will decide not to participate following a 10 minute MRI scan which will allow subjects to experience the procedure.
- The finding of a Random Space Occupying Lesion on MRI scan at initial anatomical assessment.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read more
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.
Read the detailed description
Introduction
In recent decades, with the increase in life expectancy, the number of older people and their relative rate within the population have risen dramatically. This trend led to increased rates of people suffering from a mild cognitive disorder and dementia in developed countries. Mild Neurocognitive Disorder or Mild Cognitive Impairment (MCI) is defined as a transition state between successful aging and a state of dementia. This state is characterized by cognitive impairment and a decline in memory skills while daily functioning is maintained.
Older people diagnosed with MCI are at increased risk of developing dementia, particularly Alzheimer's disease. This risk is ranked at about 12% every year.
Since this is a pre-dementia stage, great importance lies in finding methods that may prevent or at least decelerate the progress of MCI to dementia. Cognitive training is believed to be an appropriate intervention for preserving cognitive function.
The Feuerstein Program
This program is designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above (hereinafter "The Feuerstein Program"). The program is the initiative and brainchild of Professor Reuven Feuerstein - Israel Prize Laureate, founder and President of the Feuerstein Institute for the Enhancement of Learning Potential.
The program is based on the theories of Structural Cognitive Modifiability as well as on Mediated Learning Experience. For the needs of this program, the tools were suited to the unique characteristics and requirements of the older population.
The program is composed of a variety of tools (hereinafter: instrumental enrichment) that offer systematic activities intended to stimulate mental and cognitive development.
Instrumental enrichment is a set of tools dealing with required thinking skills to promote learning and thinking processes. The tasks of the various tools are free of educational content and they engage in pure learning and thinking processes. The tools are delivered through a special mediation approach, in which teachers and supervisors are trained in specialized courses.
Objectives of the Feuerstein Program
The main objective: to enhance the transformation (variability) capacity of a human being.
The sub-objectives:
- Correction and development of defective thinking skills, that are responsible for learning difficulties and the absence of transformation (variability).
- Equipping the learner with literal and conceptual content that he requires during his learning processes.
- Creating and establishing proper sound thinking and working habits.
- Creating insight and awareness regarding the processes involved in learning.
- Creating internal motivation for carrying out tasks.
The Learning Process
The instrumental enrichment tools are distributed to the participant as work sheets. The teacher creates a "mediating" dialogue between himself and the participants, thus enabling them to construct learning skills and essential thinking strategies. In addition, the teacher bridges the learning skills that were studied to the daily life of the older participant.
Products
- Creating within them awareness to their learning and thinking processes (Metacognition) while introducing an optimistic and positive attitude towards the ability to effect a significant change in these areas.
- Instill the older person with control over his thinking skills.
- Enhancing the sense of capability of the older person.
The Intervention Focuses of the Instrumental Enrichment Tools that will be utilized in the Program
- Methodical information gathering.
- Orientation and function in space and time.
- Comparison and sorting capabilities.
- Memory.
- Raising hypotheses and their examination.
- Perspicuousness (clear wording) and naming capabilities.
MRI imaging
The current study includes anatomical and functional MRI imaging in order to evaluate the relationship between cognitive changes and brain functional connectivity.
Research Objective
Examining the effects of the Feuerstein Program on brain functional connectivity as measured by MRI and cognitive function assessed by a computerized cognitive battery in subjects with MCI.
Research Hypothesis
The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity.
Methodology
An open-label single group interventional study.
Research Assessment Tools
- Cognitive screening by means of the MoCA (Montreal Cognitive Assessment) Test.
- CogSym (Cognitive Symptom) Meta-cognition questionnaire composed of ten items related to the cognitive ability of the examinee during his daily functioning. The examinee is asked to assess for each item, what is his ability level for the function being described, on a 5 levels scale (1 = excellent, 5 = inferior).
- World Health Organization well-being index questionnaire.
- The Neurotrax computerized cognitive assessment battery.
- Anatomical and functional MRI imaging
The intervention
Phase 1:
15 participants will undergo the aforementioned assessments at baseline followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Phase 2:
15 participants will undergo the aforementioned assessments initially, followed by a waiting period of 15 weeks without intervention (baseline function). This will be followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Data Analysis The statistical analysis will be conducted as is customary in clinical research within the field.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Feuerstein Program
- Keywords
- Older people, Cognitive training, MCI
- 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 ProgramBehavioural
Mediated learning cognitive enhancement program
| Study group | Role | What they receive |
|---|---|---|
| Feuerstein Program | Experimental | All subjects participating in the Feuerstein Program will be evaluated by anatomical and functional MRI as well as computerized cognitive assessment prior to and following intervention as outlined in the protocol. Receives: Behavioral: Feuerstein Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline functional connectivity
Based on correlation coefficient of FMRI signal between brain regions
Measured: Through study completion, an average of 11 months
Secondary outcomes (1)
Change from baseline cognitive function
Based on Neurotrax computerized neuropsychological assessment battery
Measured: Through study completion, an average of 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start4 Jul 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Adolf und Mary Mil-Stiftung, Helen Bader Foundation, Montreal Jewish Community Fund, Rochlin Family Foundation
- Responsible party
- Principal investigator, Tzvi Dwolatzky, Rambam Health Care Campus
- Investigators
- Tzvi Dwolatzky, MD MBBCh, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447236
- Sponsor's protocol ID
- 0580-16-RMB
- Status last verified
- Sep 2019
- First submitted
- 18 Feb 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1186/1471-2318-3-4.
PubMed 14594456Lifshitz 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.
PubMed 23124009Hostage 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.
PubMed 24475827Esposito 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.
PubMed 24010015Deng 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.
PubMed 27582703Li 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.
PubMed 26843991Meskaldji 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. doi: 10.1016/j.nicl.2016.10.004. eCollection 2016.
PubMed 27812505Wells 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.
PubMed 24120430Eyre 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.
PubMed 27060939Topp CW, Ostergaard SD, Sondergaard 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.
PubMed 25831962Karahanoglu 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.
PubMed 26178017Allan 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.
PubMed 25922945
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03447236
- Acronym / sponsor ID
- 0580-16-RMB
- Conditions
- Mild Cognitive Impairment
- Keywords
- Older people, Cognitive training, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Adolf und Mary Mil-Stiftung, Helen Bader Foundation, Montreal Jewish Community Fund, Rochlin Family Foundation
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 27 Feb 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.
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.
Detailed description
Introduction
In recent decades, with the increase in life expectancy, the number of older people and their relative rate within the population have risen dramatically. This trend led to increased rates of people suffering from a mild cognitive disorder and dementia in developed countries. Mild Neurocognitive Disorder or Mild Cognitive Impairment (MCI) is defined as a transition state between successful aging and a state of dementia. This state is characterized by cognitive impairment and a decline in memory skills while daily functioning is maintained.
Older people diagnosed with MCI are at increased risk of developing dementia, particularly Alzheimer's disease. This risk is ranked at about 12% every year.
Since this is a pre-dementia stage, great importance lies in finding methods that may prevent or at least decelerate the progress of MCI to dementia. Cognitive training is believed to be an appropriate intervention for preserving cognitive function.
The Feuerstein Program
This program is designed to prevent mental deterioration and preserve cognitive abilities among people aged 60 and above (hereinafter "The Feuerstein Program"). The program is the initiative and brainchild of Professor Reuven Feuerstein - Israel Prize Laureate, founder and President of the Feuerstein Institute for the Enhancement of Learning Potential.
The program is based on the theories of Structural Cognitive Modifiability as well as on Mediated Learning Experience. For the needs of this program, the tools were suited to the unique characteristics and requirements of the older population.
The program is composed of a variety of tools (hereinafter: instrumental enrichment) that offer systematic activities intended to stimulate mental and cognitive development.
Instrumental enrichment is a set of tools dealing with required thinking skills to promote learning and thinking processes. The tasks of the various tools are free of educational content and they engage in pure learning and thinking processes. The tools are delivered through a special mediation approach, in which teachers and supervisors are trained in specialized courses.
Objectives of the Feuerstein Program
The main objective: to enhance the transformation (variability) capacity of a human being.
The sub-objectives:
- Correction and development of defective thinking skills, that are responsible for learning difficulties and the absence of transformation (variability).
- Equipping the learner with literal and conceptual content that he requires during his learning processes.
- Creating and establishing proper sound thinking and working habits.
- Creating insight and awareness regarding the processes involved in learning.
- Creating internal motivation for carrying out tasks.
The Learning Process
The instrumental enrichment tools are distributed to the participant as work sheets. The teacher creates a "mediating" dialogue between himself and the participants, thus enabling them to construct learning skills and essential thinking strategies. In addition, the teacher bridges the learning skills that were studied to the daily life of the older participant.
Products
- Creating within them awareness to their learning and thinking processes (Metacognition) while introducing an optimistic and positive attitude towards the ability to effect a significant change in these areas.
- Instill the older person with control over his thinking skills.
- Enhancing the sense of capability of the older person.
The Intervention Focuses of the Instrumental Enrichment Tools that will be utilized in the Program
- Methodical information gathering.
- Orientation and function in space and time.
- Comparison and sorting capabilities.
- Memory.
- Raising hypotheses and their examination.
- Perspicuousness (clear wording) and naming capabilities.
MRI imaging
The current study includes anatomical and functional MRI imaging in order to evaluate the relationship between cognitive changes and brain functional connectivity.
Research Objective
Examining the effects of the Feuerstein Program on brain functional connectivity as measured by MRI and cognitive function assessed by a computerized cognitive battery in subjects with MCI.
Research Hypothesis
The Feuerstein Program will improve cognitive abilities and affect brain functional connectivity.
Methodology
An open-label single group interventional study.
Research Assessment Tools
- Cognitive screening by means of the MoCA (Montreal Cognitive Assessment) Test.
- CogSym (Cognitive Symptom) Meta-cognition questionnaire composed of ten items related to the cognitive ability of the examinee during his daily functioning. The examinee is asked to assess for each item, what is his ability level for the function being described, on a 5 levels scale (1 = excellent, 5 = inferior).
- World Health Organization well-being index questionnaire.
- The Neurotrax computerized cognitive assessment battery.
- Anatomical and functional MRI imaging
The intervention
Phase 1:
15 participants will undergo the aforementioned assessments at baseline followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Phase 2:
15 participants will undergo the aforementioned assessments initially, followed by a waiting period of 15 weeks without intervention (baseline function). This will be followed by an intervention period involving 30 twice weekly sessions of the Feuerstein Program each lasting 90 minutes over 15 weeks. Assessments will be repeated after session 30 and finally at 9 months following intervention commencement.
Data Analysis The statistical analysis will be conducted as is customary in clinical research within the field.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feuerstein Program | Experimental | Behavioral: Feuerstein ProgramAll subjects participating in the Feuerstein Program will be evaluated by anatomical and functional MRI as well as computerized cognitive assessment prior to and following intervention as outlined in the protocol. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 and above.
- Hebrew speakers.
- Expressing willingness to participate in the research and deliberately signing a consent form.
- 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).
Key exclusion criteria (9 listed)
- A medical or functional condition that will not allow the subject to participate in the intervention program within the research period.
- Diagnosed subjects suffering from active depression, bipolar disorder or schizophrenia.
- Subjects who suffer from a diagnosed cognitive impairment other than MCI (delirium dementia or mental retardation).
- Visual impairment that will not allow subjects to observe detailed information on a 32' screen from a distance of 1 meter.
- Hearing impairment that will not allow subjects to listen to instructions during assessment.
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 |
|---|---|---|
| Feuerstein ProgramMediated learning cognitive enhancement program | Behavioural | Feuerstein Program |
Primary outcome
Change from baseline functional connectivity
Time frame: Through study completion, an average of 11 months
Based on correlation coefficient of FMRI signal between brain regions
1 secondary outcome
Change from baseline cognitive function
Time frame: Through study completion, an average of 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Background: PubMed 14594456Dwolatzky 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. doi: 10.1186/1471-2318-3-4.
- Background: PubMed 23124009Lifshitz 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.
- Background: PubMed 24475827Hostage 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.
- Background: PubMed 24010015Esposito 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.
- Background: PubMed 27582703Deng 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.
- Background: PubMed 26843991Li 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.
- Background: PubMed 27812505Meskaldji 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. doi: 10.1016/j.nicl.2016.10.004. eCollection 2016.
- Background: PubMed 24120430Wells 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.
- Background: PubMed 27060939Eyre 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.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard 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.
- Background: PubMed 26178017Karahanoglu 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.
- Background: PubMed 25922945Allan 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.
- Individual participant dataSharing planned: No
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
Tzvi Dwolatzky, MD MBBCh principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feuerstein Program in people with Mild Cognitive Impairment, run by Rambam Health Care Campus 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 4 inclusion and 9 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 17 Sep 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?
Change from baseline functional connectivity (time frame: Through study completion, an average of 11 months). 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 NCT03447236, which also lists 12 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 17 Sep 2019.