Mild Cognitive Impairment, So StatedPSCogStimNCT03195829
Feasibility Study of a Computerized Cognitive Stimulation
A study testing Computerized Cognitive Stimulation and Multimedia-based internet in people with Mild Cognitive Impairment, So Stated, run by Leila DJABELKHIR.
Trial summary
This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, So Stated
- What is being tested?
- Computerized Cognitive Stimulation and Multimedia-based internet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jul 2016
- 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
- Clinical diagnosis of Mild Cognitive Impairment
- Absence of history of alcohol or other substance consumption
- No engagement in other cognitive intervention program
Who cannot join
- Psychiatric and neurological disorders
- Conversion toward dementia during intervention
- Sensory and or motor deficit that could interfere with the use of computer tool
About this study
Official title: A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study
This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.
Read the 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.
- Conditions
- Mild Cognitive Impairment, So Stated
- Being tested
- Computerized Cognitive Stimulation, Multimedia-based internet
- Keywords
- Mild Cognitive Impairment, Computerized Cognitive Stimulation, Cognition, Psychosocial factors
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive StimulationBehavioural
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.
Multimedia-based internetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive stimulation | Experimental | Computerized Cognitive Stimulation was administered to intervention group (IG). Receives: Behavioral: Computerized Cognitive Stimulation |
| Multimedia-based internet activities | Active comparator | Multimedia-based internet activities was administered to active control group (ACG). Receives: Behavioral: Multimedia-based internet |
What is being measured
The primary outcome is the main question the study is designed to answer.
GROBER-BUSCHKE TEST
Assessment of free and cued recall of episodic memory
Measured: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
Secondary outcomes (1)
Technologies Acceptation Questionnaire
Assessment of acceptability of communication and information technologies
Measured: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment, So StatedStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled pilot study, single blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leila DJABELKHIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leila DJABELKHIR, Broca Hospital
- Investigators
- Anne-Sophie AR RIGAUD, Professor, Principal investigator, Broca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195829
- Sponsor's protocol ID
- LUSAGE
- Acronym
- PSCogStim
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03195829
- Acronym / sponsor ID
- PSCogStim / LUSAGE
- Conditions
- Mild Cognitive Impairment, So Stated
- Keywords
- Mild Cognitive Impairment, Computerized Cognitive Stimulation, Cognition, Psychosocial factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leila DJABELKHIRUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jun 2017 (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.
This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled pilot study, single blind
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive stimulation | Experimental | Behavioral: Computerized Cognitive StimulationComputerized Cognitive Stimulation was administered to intervention group (IG). |
| Multimedia-based internet activities | Active comparator | Behavioral: Multimedia-based internetMultimedia-based internet activities was administered to active control group (ACG). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Mild Cognitive Impairment
- Absence of history of alcohol or other substance consumption
- No engagement in other cognitive intervention program
Key exclusion criteria (3 listed)
- Psychiatric and neurological disorders
- Conversion toward dementia during intervention
- Sensory and or motor deficit that could interfere with the use of computer tool
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 |
|---|---|---|
| Computerized Cognitive StimulationThe 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. | Behavioural | Computerized cognitive stimulation |
| Multimedia-based internetThe 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. | Behavioural | Multimedia-based internet activities |
Primary outcome
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
1 secondary outcome
Technologies Acceptation Questionnaire
Time frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
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 22 Jun 2017.
- Individual participant dataSharing planned: No
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.
Anne-Sophie AR RIGAUD, Professor principal investigator
Broca University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Stimulation and Multimedia-based internet in people with Mild Cognitive Impairment, So Stated, run by Leila DJABELKHIR.
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 3 inclusion and 3 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
GROBER-BUSCHKE TEST (time frame: Baseline assessment before intervention, change from baseline at 3 months immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2017.