Condition category
Nervous System Diseases
Date applied
02/05/2013
Date assigned
22/05/2013
Last edited
23/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 adult’s 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

Contact information

Type

Scientific

Primary contact

Prof Nicola Mammarella

ORCID ID

Contact details

Department of Psychological Sciences
Via dei Vestini 31
Chieti
66100
Italy

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

Sponsor information

Organisation

University of Chieti (Università degli Studi 'G. d'Annunzio' Chieti e Pescara) (Italy)

Sponsor details

Via dei Vestini
31
Chieti
66100
Italy

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes