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Memory for Action in Neurological Patients (EMBODIMENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844855
Recruitment Status : Terminated (failure to recruit 83/99)
First Posted : July 26, 2016
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief Summary:

Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease.

If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Parkinson Disease Behavioral: Cognitive tests Not Applicable

Detailed Description:
  1. = Folstein et al., 1975,
  2. = Zigmond & Snaith, 1983,
  3. = Dubois et al., 2002;
  4. = Godefroy et al., 2008;
  5. = Dubois et Pillon, 2000;
  6. = Mahieux-Laurent, 2009.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Memory for Action in Neurological Patients
Actual Study Start Date : December 26, 2016
Actual Primary Completion Date : February 21, 2020
Actual Study Completion Date : February 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: patients with Alzheimer disease
Behavioral: Cognitive tests Only patients with Alzheimer disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
 Behavioral: Cognitive tests
MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Active Comparator: patients with Parkinson disease
Behavioral: Cognitive tests Only patients with Parkinson disease will be included in this arm. Patients will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
 Behavioral: Cognitive tests
MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
Sham Comparator: healthy controls
Behavioral: Cognitive tests Only patients with healthy controls will be included in this arm. Controls will perform different tasks : MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
 Behavioral: Cognitive tests
MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).


Outcome Measures
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Primary Outcome Measures :
  1. Number of correct answers [ Time Frame: Day 1 ]
    The gain provided by the verbal learning vs action learning (number of correct answers).


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for 3 arms:

  • Patient affiliated to a social security system
  • Age between 55 and 80 years
  • Normal vision and hearing or successfully corrected
  • French mother tongue
  • Signature of consent by participants

Specific criteria for inclusion of MA patients:

  • Probable AD diagnosis made by a neurologist (McKhann et al., 2011)
  • Mini-Mental State Examination (MMSE): score > 22
  • Stable treatment for two months minimum.

Specific criteria for inclusion of PD patients:

  • PD diagnosed by a neurologist (Postuma et al., 2015)
  • Stable treatment for two months minimum.
  • Mini-Mental State Examination (MMSE): score > 27
  • Under dopaminergic treatment

Exclusion Criteria for 3 arms:

  • Other neurological or psychiatric history
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • Inability to communicate
  • Significant impairment of judgment
  • Delusional or psychotic state

Criteria common for non-inclusion of AD and PD patients:

  • Other neurological or psychiatric history
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
  • Inability to communicate
  • Significant impairment of judgment
  • Delusional or psychotic state

Criteria for non-inclusion of PD patients:

- Motor fluctuations

Criteria for non-inclusion of controls:

  • Psychiatric or neurological disorders
  • Anxiety and depressive symptoms (assessed by the scale of depression-anxiety HAD; Zigmond & Snaith, 1983)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844855


Locations
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France
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Hcl - Cm2R
Villeurbanne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Céline BORG, MD celine.borg@univ-st-etienne.fr
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02844855    
Other Study ID Numbers: 1608068
2016-A00891-50 ( Other Identifier: ANSM )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Alzheimer
Parkinson
Action memory
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders