Non-invasive Brain Stimulation and Strategic Memory Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
Physiological aging is often associated with memory function decline. Recently, the use of transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation, has been combined with adaptive working memory training interventions in healthy older adults, providing evidence for a significant improvement in memory functions. To the best of our knowledge, no study addressed the use of strategic memory training coupled with the use of tDCS in normal aging. Strategic memory trainings allow to improve participants' performance in the practiced task and to generalize the use of memory strategies to new materials. This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a combined intervention associating strategic memory training with the use of tDCS. Healthy older adults and participants with subjective cognitive decline will be recruited and randomly assigned to the experimental group (strategic memory training + ACTIVE tDCS) or the control group (strategic memory training + SHAM tDCS). All participants will be evaluated on transfer and practiced tasks before (T0) and after (T1) the treatment and during follow-up visits, scheduled at 1 month (T2) and 3 months (T3) after the intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
MMSE ≥ 24.
GDS < e uguale 11.
Age between 65 and 85 years.
Educational level ≥ 5 years.
Disqualifiers
Pre-existing cognitive impairment (e.g. aphasia, neglect).
Dementia.
Severe disturbances in consciousness.
Concomitant severe psychiatric disease or other neurological conditions (e.g. depression and behavioral disorders).
Trial design
Design model
Parallel
Treatments tested in this trial
Non-invasive brain stimulation
Other interventionACTIVE transcranial direct current stimulation( tDCS)
Sham non-invasive brain stimulation
Other interventionSHAM tDCS
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Associative learning test scores
Participants are presented with 40 paired associates. Pairs consist of words chosen from Paivio, Yuille, and Madigan (1968) concreteness and imagery norms and from De Mauro, Mancini, Vedovelli, and Voghera (1993) word frequency norms. Each pair is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the pairs for up to 20 minutes. After study, each stimulus is individually presented, and participants Are asked to write the corresponding response
Time frame
Immediately after the intervention program (T1).2
Associative learning test scores
Participants are presented with 40 paired associates. Pairs consist of words chosen from Paivio, Yuille, and Madigan (1968) concreteness and imagery norms and from De Mauro, Mancini, Vedovelli, and Voghera (1993) word frequency norms. Each pair is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the pairs for up to 20 minutes. After study, each stimulus is individually presented, and participants Are asked to write the corresponding response
Time frame
1 month (T2) after the end of the intervention program.3
Associative learning test scores
Participants are presented with 40 paired associates. Pairs consist of words chosen from Paivio, Yuille, and Madigan (1968) concreteness and imagery norms and from De Mauro, Mancini, Vedovelli, and Voghera (1993) word frequency norms. Each pair is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the pairs for up to 20 minutes. After study, each stimulus is individually presented, and participants Are asked to write the corresponding response
Time frame
3 months (T3) after the end of the intervention program.Secondary outcomes
1
List learning tests scores
Participants are presented with 40 words. Words are also taken from Paivio Yuille, and Madigan (1968) and De Mauro, Mancini, Vedovelli, and Voghera (1993) norms. Each word is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the words for up to 20 minutes. After study, participants are asked to write down as many words as they could remember (in any order) on an answer sheet.
Time frame
Immediately after the intervention program (T1).2
List learning tests scores
Participants are presented with 40 words. Words are also taken from Paivio Yuille, and Madigan (1968) and De Mauro, Mancini, Vedovelli, and Voghera (1993) norms. Each word is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the words for up to 20 minutes. After study, participants are asked to write down as many words as they could remember (in any order) on an answer sheet.
Time frame
1 month (T2) after the end of the intervention program.3
List learning tests scores
Participants are presented with 40 words. Words are also taken from Paivio Yuille, and Madigan (1968) and De Mauro, Mancini, Vedovelli, and Voghera (1993) norms. Each word is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the words for up to 20 minutes. After study, participants are asked to write down as many words as they could remember (in any order) on an answer sheet.
Time frame
3 months (T3) after the end of the intervention program.4
Name-face learning test scores
Participants are presented with 20 black and white photographs of faces (2.75 x 4) paired with the last name printed below it. The 20 name-face cards are handed to participants, who are instructed to study the pairs for up to 20 minutes. After study, each face is individually presented, and participants are asked to write down the name that had been previously paired with it.
Time frame
Immediately after the intervention program (T1).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
University of Pavia
Collaborator
Source ClinicalTrials.gov
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