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Feasibility Study of a Computerized Cognitive Stimulation (PSCogStim)

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ClinicalTrials.gov Identifier: NCT03195829
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leila DJABELKHIR, Broca Hospital

Brief Summary:
This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment, So Stated Behavioral: Computerized Cognitive Stimulation Behavioral: Multimedia-based internet Not Applicable

Detailed Description:

Involvement in social and leisure activities has been associated with a decreased risk of dementia in the elderly with Mild Cognitive Impairment (MCI). MCI is a crucial phase to prevent the worsening of cognitive decline in elderly at risk to develop dementia. These last years, the use of computerized training programs to enhance cognitive functioning showed positive and promising results. However, the effects on psychosocial factors still poorly documented in cognitive interventions in MCI. It seems essential to promote these factors involving social ties, group dynamic, the motivation, as factors that can contribute to enhance social life and cognitive functioning.

This feasibility study evaluated a computer-based cognitive stimulation in elderly with MCI and explore the effects on cognitive and psychosocial components.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled pilot study, single blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study
Study Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Computerized cognitive stimulation
Computerized Cognitive Stimulation was administered to intervention group (IG).
Behavioral: Computerized Cognitive Stimulation
The intervention group performed 12-week, 90-minutes per week of cognitive stimulation in group using a tablet with a commercial software with specific exercises to train the cognitive functioning and promote the relation ties in group-session.The program's difficulty level was adjusted to the MMSE score, and was gradually increased.

Active Comparator: Multimedia-based internet activities
Multimedia-based internet activities was administered to active control group (ACG).
Behavioral: Multimedia-based internet
The active control group had access to different Multimedia contents (travel, photos, music, TV program, cooking recipes) using a tablet, 90-minutes per week each week during 3-months. Each group session was centered in a particular topic, participants were able to select different media free available in Internet.




Primary Outcome Measures :
  1. GROBER-BUSCHKE TEST [ Time Frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention ]
    Assessment of free and cued recall of episodic memory


Secondary Outcome Measures :
  1. Technologies Acceptation Questionnaire [ Time Frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention ]
    Assessment of acceptability of communication and information technologies



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Mild Cognitive Impairment
  • Absence of history of alcohol or other substance consumption
  • No engagement in other cognitive intervention program

Exclusion Criteria:

  • Psychiatric and neurological disorders
  • Conversion toward dementia during intervention
  • Sensory and or motor deficit that could interfere with the use of computer tool

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): NCT03195829


Sponsors and Collaborators
Leila DJABELKHIR
Investigators
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Principal Investigator: Anne-Sophie AR RIGAUD, Professor Broca University Hospital

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Responsible Party: Leila DJABELKHIR, Neuropsychologist, Broca Hospital
ClinicalTrials.gov Identifier: NCT03195829     History of Changes
Other Study ID Numbers: LUSAGE
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Leila DJABELKHIR, Broca Hospital:
Mild Cognitive Impairment
Computerized Cognitive Stimulation
Cognition
Psychosocial factors
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders