Plain English Summary
Background and study aims
Pre-stimulus cues seem to increase the ability to process things better and faster. However, the impact this may have on memory in older adults, has received little or no attention. Our study investigates whether pre-stimulus cueing has any effects on older adults memory and to what extent.
Who can participate?
The PRESTIcue study recruits about 30 younger (age>18 years) and 30 older (age>60 years) adults from the local community.
What does the study involve?
Participants will be invited to study a series of words that will be presented on a computer screen. Some of the words will be preceded by a cue (e.g. a signalling picture), while some others will be preceded by a blank screen. After a brief retention interval, they will be asked to recall all the words they can remember. All participants will study words with both pre-stimulus cueing and no cueing. The session will last about 40 minutes.
What are the possible benefits and risks of participating?
We expect immediate and direct benefits on participants' memory as they should remember items that will be preceded by a cue better, when compared to items with no cue. This will indicate that pre-stimulus cueing may be a useful strategy to be used in older adults everyday memory tasks. No risks are involved.
Where is the study run from?
The PRESTIcue study has been set up by the Psychogerontology Centre at the University of Chieti.
When is study starting and how long is it expected to run for?
Recruitment starts in mid-May 2013. The study is expected to end by July 2013.
Who is funding the study?
University of Chieti (Italy)
Who is the main contact?
Professor Nicola Mammarella
n.mammarella@unich.it
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving older adults memory with a PRE-STImulus cueing-based behavioral intervention: a controlled pilot study
Acronym
PRESTIcue
Study hypothesis
We hypothesise that older adults memory will be improved after a pre-stimulus cueing intervention vs no cueing. The null hypothesis is that there will be no difference in memory between conditions; this may arise if older adults are not sensitive to pre-stimulus cueing information.
Ethics approval
Departmental Ethics Board; 22/05/2013; ref. number 001
Study design
Controlled pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Aging and memory difficulties
Intervention
The study will involve 15 male and 15 female younger adults and 15 male and 15 female older adults. Participation will be tested on a memory task. This task will include a study phase during which a series of words will be either preceded by a cue (intervention trials) vs. no-cue (no intervention). After the study phase, participants will be asked to recall as many of the studied words they can remember. Male participants will be assigned to standard 12-week vs 10-week vs 8-week inter-donation intervals and female participants to 16-week vs 14-week vs 12-week intervals.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Cognitive: memory abilities measured immediately followingthe experimental stimuli presentation in a single session
Secondary outcome measures
No secondary outcome will be considered
Overall trial start date
30/05/2013
Overall trial end date
31/07/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age range for younger adults >18 < 30 years
2. Age range for older adults >60 < 80 years
3. Half of participants will be male, the other half female
4. All participants must be native Italian speakers
5. Willing to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Participants with history of head trauma, alcohol or drug abuse, or neurological or psychiatric disorders
2. Participants reporting taking medication affecting the central nervous system
Recruitment start date
30/05/2013
Recruitment end date
31/07/2013
Locations
Countries of recruitment
Italy
Trial participating centre
Department of Psychological Sciences
Chieti
66100
Italy
Funders
Funder type
University/education
Funder name
University of Chieti (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary