EMBODIMENT: Memory for Action in Neurological Patients

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Terminated
CT.gov ID
NCT02844855
Collaborator
(none)
83
2
3
37.8
41.5
1.1

Study Details

Study Description

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
  • Behavioral: Cognitive tests
N/A

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

Study Type:
Interventional
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 :
Dec 26, 2016
Actual Primary Completion Date :
Feb 21, 2020
Actual Study Completion Date :
Feb 21, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Number of correct answers [Day 1]

    The gain provided by the verbal learning vs action learning (number of correct answers).

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 CHU de Saint-Etienne Saint-Etienne France 42055
2 Hcl - Cm2R Villeurbanne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: CĂ©line BORG, MD, celine.borg@univ-st-etienne.fr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT02844855
Other Study ID Numbers:
  • 1608068
  • 2016-A00891-50
First Posted:
Jul 26, 2016
Last Update Posted:
Sep 17, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2020