Cognitive DeclineStMe-tDCSNCT05929872
Non-invasive Brain Stimulation and Strategic Memory Training
A study testing Non-invasive brain stimulation in people with Cognitive Decline and Healthy Aging, run by IRCCS National Neurological Institute "C. Mondino" Foundation.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Healthy Aging
- What is being tested?
- Non-invasive brain stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- MMSE ≥ 24.
- GDS < e uguale 11.
- Age between 65 and 85 years.
- Educational level ≥ 5 years.
Who cannot join
- 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).
- Motor or sensory diseases that may interfere with test execution or strategic memory training.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Strategic Memory Training Coupled With Non-invasive Brain Stimulation Techniques in Healthy Aging Population and Subjective Cognitive Decline Patients: a Randomized-controlled Study
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.
Read the detailed description
The use of cognitive functions such as memory is essential for the execution of daily activities and represents a crucial element for autonomy maintenance during aging. It is known that the physiological cognitive decline associated with aging also involves memory and can significantly impact the older person's independence. For these reasons, great interest has been generated by two tools that have proved to be decisive in supporting memory functions: non-invasive neurostimulation and memory training. Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that modulates brain activity by employing a direct current delivered through electrodes applied to the scalp. Recently, the use of tDCS has been combined with training interventions focused on working memory in healthy older adults, providing evidence of a significant improvement in memory function when memory training is associated with the use of tDCS compared to when it is performed without it. In particular, adaptive memory trainings coupled with stimulation of the dorsolateral prefrontal cortex provide benefits that last also at follow-up visits after 1 or 3 months, especially in participants who exhibit a lower baseline performance.
While it was observed that adaptive working memory training alone is unable to modulate brain plasticity mechanisms, it was hypothesized that tDCS can modulate brain plasticity by acting through long-term potentiation (LTP) mechanisms and that it can modulate brain neurotrophic factor (BDNF), a protein that plays a relevant role in LTP.
Several adaptive memory trainings focused on working memory, which is essential for decision-making processes and daily activities.
Even if promising results have been shown so far, it appears that no study addressed the implementation of strategic memory training coupled with the use of tDCS. Adaptive trainings allow improving the performance in each task by gradually increasing its difficulty, without however resorting to teaching a strategy. Strategic memory trainings permit not only to improve participants' performance in the practiced task but also to generalize the use of memory strategies to new tasks.
Intending to prevent cognitive impairment, using these intervention methods in healthy aging and the prodromal phases can be useful. To this end, subjective cognitive decline (SCD) indeed represents an intermediate state between normal cognition and mild cognitive impairment (nMCD) and may predict the development of objective cognitive decline.
In this frame, the primary goal of this double-blind randomized controlled trial is to assess whether the application of transcranial direct current stimulation during strategic memory training (on-line neurostimulation) enhances the effect of strategic memory training. The follow-up visits allow for investigating whether eventual improvements are preserved over time and if this combined intervention affects the evolution of cognitive decline.
The treatment protocol consists of 5 sessions (2/3 session/week, 1 hour/day) of strategic memory training combined with on-line tDCS (anodic tDCS, 2mA for 20 minutes, versus sham tDCS, applied to the dorsolateral prefrontal cortex - DLPFC).
Healthy old participants will be recruited from the general population. Participants with subjective cognitive decline (SCD) are recruited from Neuropsychology/Alzheimer's Disease Assessment Unit and Neurorehabilitation Unit of IRCCS Mondino Foundation. The diagnosis of SCD is formulated based on a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature.
At T0, the following standardized tests are used:
- Global cognitive function is assessed using Mini-Mental State Examination (MMSE);
- Cognitive reserve is assessed using Cognitive Reserve Index Questionnaire (CRIq);
- Mood is assessed using Geriatric Depression Scale (GDS).
At T0, practiced and not practiced memory tasks (Bottiroli et al., 2013) will be administered to the participants as pre-tests:
- Associative learning;
- List learning;
- Name-face learning;
- Place learning;
- Text learning;
- Grocery learning;
Participants who met the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group (strategic memory training + ACTIVE tDCS) or control group (strategic memory training + SHAM tDCS).
- Conditions
- Cognitive Decline, Healthy Aging
- Being tested
- Non-invasive brain stimulation, Sham non-invasive brain stimulation
- Keywords
- Healthy aging, Subjective cognitive decline, Non-pharmacological treatments, Memory training, Transcranial direct current stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulationOther
ACTIVE transcranial direct current stimulation( tDCS)
Sham non-invasive brain stimulationOther
SHAM tDCS
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group receives strategic memory training plus non-invasive brain stimulation (ACTIVE tDCS). Receives: Other: Non-invasive brain stimulation |
| Control Group | Sham comparator | The control group receives strategic memory training plus sham non-invasive brain stimulation (SHAM tDCS). Receives: Other: Sham non-invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the intervention program (T1).
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
Measured: 1 month (T2) after the end of the intervention program.
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
Measured: 3 months (T3) after the end of the intervention program.
Secondary outcomes (15)
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.
Measured: Immediately after the intervention program (T1).
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.
Measured: 1 month (T2) after the end of the intervention program.
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.
Measured: 3 months (T3) after the end of the intervention program.
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.
Measured: Immediately after the intervention program (T1).
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.
Measured: 1 month (T2) after the end of the intervention program.
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.
Measured: 3 months (T3) after the end of the intervention program.
Place learning test scores
Participants are presented a map of a city. The map includes the location and name of 20 target places (e.g., bank) across the streets of an imaginary city. They are given up to 15 minutes to study, and then they have to write the position and name of places on a blank map.
Measured: Immediately after the intervention program (T1).
Place learning test scores
Participants are presented a map of a city. The map includes the location and name of 20 target places (e.g., bank) across the streets of an imaginary city. They are given up to 15 minutes to study, and then they have to write the position and name of places on a blank map.
Measured: 1 month (T2) after the end of the intervention program.
Place learning test scores
Participants are presented a map of a city. The map includes the location and name of 20 target places (e.g., bank) across the streets of an imaginary city. They are given up to 15 minutes to study, and then they have to write the position and name of places on a blank map.
Measured: 3 months (T3) after the end of the intervention program.
Text learning test scores
Participants are presented with a short story with 22 major ideas (e.g., It was a quiet Sunday at Tirano railway station./ The locomotive, to which the carriages had already been coupled, was standing on the track./ The engine driver and his assistants got down to make sure everything was all right./ Some damage to the brakes...). They have up to 15 minutes to study the story, and then they are asked to recall and write down as much as possible from memory.
Measured: Immediately after the intervention program (T1).
Text learning test scores
Participants are presented with a short story with 22 major ideas (e.g., It was a quiet Sunday at Tirano railway station./ The locomotive, to which the carriages had already been coupled, was standing on the track./ The engine driver and his assistants got down to make sure everything was all right./ Some damage to the brakes...). They have up to 15 minutes to study the story, and then they are asked to recall and write down as much as possible from memory.
Measured: 1 month (T2) after the end of the intervention program.
Text learning test scores
Participants are presented with a short story with 22 major ideas (e.g., It was a quiet Sunday at Tirano railway station./ The locomotive, to which the carriages had already been coupled, was standing on the track./ The engine driver and his assistants got down to make sure everything was all right./ Some damage to the brakes...). They have up to 15 minutes to study the story, and then they are asked to recall and write down as much as possible from memory.
Measured: 3 months (T3) after the end of the intervention program.
Grocery learning test scores
Participants are presented with a list of 40 grocery items (e.g., butter). Each item 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 15 minutes. In the recall phase, participants are asked to write down as many grocery items (in any order) as they could remember.
Measured: Immediately after the intervention program (T1).
Grocery learning test scores
Participants are presented with a list of 40 grocery items (e.g., butter). Each item 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 15 minutes. In the recall phase, participants are asked to write down as many grocery items (in any order) as they could remember.
Measured: 1 month (T2) after the end of the intervention program.
Grocery learning test scores
Participants are presented with a list of 40 grocery items (e.g., butter). Each item 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 15 minutes. In the recall phase, participants are asked to write down as many grocery items (in any order) as they could remember.
Measured: 3 months (T3) after the end of the intervention program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Sponsor
- Investigators
- Stefano Cappa, MD, Principal investigator, Dementia Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929872
- Sponsor's protocol ID
- StMe-tDCS2023
- Acronym
- StMe-tDCS
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonenko D, Thams F, Grittner U, Uhrich J, Glockner F, Li SC, Floel A. Randomized trial of cognitive training and brain stimulation in non-demented older adults. Alzheimers Dement (N Y). 2022 Feb 23;8(1):e12262. doi: 10.1002/trc2.12262. eCollection 2022.
PubMed 35229023Assecondi S, Hu R, Kroeker J, Eskes G, Shapiro K. Older adults with lower working memory capacity benefit from transcranial direct current stimulation when combined with working memory training: A preliminary study. Front Aging Neurosci. 2022 Oct 10;14:1009262. doi: 10.3389/fnagi.2022.1009262. eCollection 2022.
PubMed 36299611Bottiroli S, Cavallini E, Dunlosky J, Vecchi T, Hertzog C. The importance of training strategy adaptation: a learner-oriented approach for improving older adults' memory and transfer. J Exp Psychol Appl. 2013 Sep;19(3):205-18. doi: 10.1037/a0034078. Epub 2013 Aug 26.
PubMed 23978160Grady C. The cognitive neuroscience of ageing. Nat Rev Neurosci. 2012 Jun 20;13(7):491-505. doi: 10.1038/nrn3256.
PubMed 22714020Kane MJ, Engle RW. Working-memory capacity and the control of attention: the contributions of goal neglect, response competition, and task set to Stroop interference. J Exp Psychol Gen. 2003 Mar;132(1):47-70. doi: 10.1037/0096-3445.132.1.47.
PubMed 12656297Lu H, Cheng PL, Lim BK, Khoshnevisrad N, Poo MM. Elevated BDNF after cocaine withdrawal facilitates LTP in medial prefrontal cortex by suppressing GABA inhibition. Neuron. 2010 Sep 9;67(5):821-33. doi: 10.1016/j.neuron.2010.08.012.
PubMed 20826313Park DC, Lautenschlager G, Hedden T, Davidson NS, Smith AD, Smith PK. Models of visuospatial and verbal memory across the adult life span. Psychol Aging. 2002 Jun;17(2):299-320.
PubMed 12061414Pergher V, Au J, Alizadeh Shalchy M, Santarnecchi E, Seitz A, Jaeggi SM, Battelli L. The benefits of simultaneous tDCS and working memory training on transfer outcomes: A systematic review and meta-analysis. Brain Stimul. 2022 Nov-Dec;15(6):1541-1551. doi: 10.1016/j.brs.2022.11.008. Epub 2022 Nov 29.
PubMed 36460294Reisberg B, Shulman MB. Commentary on "a roadmap for the prevention of dementia II: Leon Thal Symposium 2008." Subjective cognitive impairment as an antecedent of Alzheimer's dementia: policy import. Alzheimers Dement. 2009 Mar;5(2):154-6. doi: 10.1016/j.jalz.2009.01.011. No abstract available.
PubMed 19328449Ripp I, Emch M, Wu Q, Lizarraga A, Udale R, von Bastian CC, Koch K, Yakushev I. Adaptive working memory training does not produce transfer effects in cognition and neuroimaging. Transl Psychiatry. 2022 Dec 13;12(1):512. doi: 10.1038/s41398-022-02272-7.
PubMed 36513642Teixeira-Santos AC, Moreira CS, Pereira DR, Pinal D, Fregni F, Leite J, Carvalho S, Sampaio A. Working Memory Training Coupled With Transcranial Direct Current Stimulation in Older Adults: A Randomized Controlled Experiment. Front Aging Neurosci. 2022 Apr 12;14:827188. doi: 10.3389/fnagi.2022.827188. eCollection 2022.
PubMed 35493937
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Strategic Memory Training Coupled With Non-invasive Brain Stimulation Techniques in Healthy Aging Population and Subjective Cognitive Decline Patients: a Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT05929872
- Acronym / sponsor ID
- StMe-tDCS / StMe-tDCS2023
- Conditions
- Cognitive Decline, Healthy Aging
- Keywords
- Healthy aging, Subjective cognitive decline, Non-pharmacological treatments, Memory training, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
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.
Detailed description
The use of cognitive functions such as memory is essential for the execution of daily activities and represents a crucial element for autonomy maintenance during aging. It is known that the physiological cognitive decline associated with aging also involves memory and can significantly impact the older person's independence. For these reasons, great interest has been generated by two tools that have proved to be decisive in supporting memory functions: non-invasive neurostimulation and memory training. Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that modulates brain activity by employing a direct current delivered through electrodes applied to the scalp. Recently, the use of tDCS has been combined with training interventions focused on working memory in healthy older adults, providing evidence of a significant improvement in memory function when memory training is associated with the use of tDCS compared to when it is performed without it. In particular, adaptive memory trainings coupled with stimulation of the dorsolateral prefrontal cortex provide benefits that last also at follow-up visits after 1 or 3 months, especially in participants who exhibit a lower baseline performance.
While it was observed that adaptive working memory training alone is unable to modulate brain plasticity mechanisms, it was hypothesized that tDCS can modulate brain plasticity by acting through long-term potentiation (LTP) mechanisms and that it can modulate brain neurotrophic factor (BDNF), a protein that plays a relevant role in LTP.
Several adaptive memory trainings focused on working memory, which is essential for decision-making processes and daily activities.
Even if promising results have been shown so far, it appears that no study addressed the implementation of strategic memory training coupled with the use of tDCS. Adaptive trainings allow improving the performance in each task by gradually increasing its difficulty, without however resorting to teaching a strategy. Strategic memory trainings permit not only to improve participants' performance in the practiced task but also to generalize the use of memory strategies to new tasks.
Intending to prevent cognitive impairment, using these intervention methods in healthy aging and the prodromal phases can be useful. To this end, subjective cognitive decline (SCD) indeed represents an intermediate state between normal cognition and mild cognitive impairment (nMCD) and may predict the development of objective cognitive decline.
In this frame, the primary goal of this double-blind randomized controlled trial is to assess whether the application of transcranial direct current stimulation during strategic memory training (on-line neurostimulation) enhances the effect of strategic memory training. The follow-up visits allow for investigating whether eventual improvements are preserved over time and if this combined intervention affects the evolution of cognitive decline.
The treatment protocol consists of 5 sessions (2/3 session/week, 1 hour/day) of strategic memory training combined with on-line tDCS (anodic tDCS, 2mA for 20 minutes, versus sham tDCS, applied to the dorsolateral prefrontal cortex - DLPFC).
Healthy old participants will be recruited from the general population. Participants with subjective cognitive decline (SCD) are recruited from Neuropsychology/Alzheimer's Disease Assessment Unit and Neurorehabilitation Unit of IRCCS Mondino Foundation. The diagnosis of SCD is formulated based on a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature.
At T0, the following standardized tests are used:
- Global cognitive function is assessed using Mini-Mental State Examination (MMSE);
- Cognitive reserve is assessed using Cognitive Reserve Index Questionnaire (CRIq);
- Mood is assessed using Geriatric Depression Scale (GDS).
At T0, practiced and not practiced memory tasks (Bottiroli et al., 2013) will be administered to the participants as pre-tests:
- Associative learning;
- List learning;
- Name-face learning;
- Place learning;
- Text learning;
- Grocery learning;
Participants who met the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group (strategic memory training + ACTIVE tDCS) or control group (strategic memory training + SHAM tDCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blind, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Non-invasive brain stimulationThe experimental group receives strategic memory training plus non-invasive brain stimulation (ACTIVE tDCS). |
| Control Group | Sham comparator | Other: Sham non-invasive brain stimulationThe control group receives strategic memory training plus sham non-invasive brain stimulation (SHAM tDCS). |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- MMSE ≥ 24.
- GDS < e uguale 11.
- Age between 65 and 85 years.
- Educational level ≥ 5 years.
Key exclusion criteria (5 listed)
- 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).
- Motor or sensory diseases that may interfere with test execution or strategic memory training.
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 |
|---|---|---|
| Non-invasive brain stimulationACTIVE transcranial direct current stimulation( tDCS) | Other | Experimental group |
| Sham non-invasive brain stimulationSHAM tDCS | Other | Control Group |
Primary outcome
Associative learning test scores
Time frame: Immediately after the intervention program (T1).
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
Associative learning test scores
Time frame: 1 month (T2) after the end of the intervention program.
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
Associative learning test scores
Time frame: 3 months (T3) after the end of the intervention program.
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
15 secondary outcomes
List learning tests scores
Time frame: Immediately after the intervention program (T1).
List learning tests scores
Time frame: 1 month (T2) after the end of the intervention program.
List learning tests scores
Time frame: 3 months (T3) after the end of the intervention program.
Name-face learning test scores
Time frame: Immediately after the intervention program (T1).
Name-face learning test scores
Time frame: 1 month (T2) after the end of the intervention program.
Name-face learning test scores
Time frame: 3 months (T3) after the end of the intervention program.
Place learning test scores
Time frame: Immediately after the intervention program (T1).
Place learning test scores
Time frame: 1 month (T2) after the end of the intervention program.
Place learning test scores
Time frame: 3 months (T3) after the end of the intervention program.
Text learning test scores
Time frame: Immediately after the intervention program (T1).
Text learning test scores
Time frame: 1 month (T2) after the end of the intervention program.
Text learning test scores
Time frame: 3 months (T3) after the end of the intervention program.
Grocery learning test scores
Time frame: Immediately after the intervention program (T1).
Grocery learning test scores
Time frame: 1 month (T2) after the end of the intervention program.
Grocery learning test scores
Time frame: 3 months (T3) after the end of the intervention program.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 35229023Antonenko D, Thams F, Grittner U, Uhrich J, Glockner F, Li SC, Floel A. Randomized trial of cognitive training and brain stimulation in non-demented older adults. Alzheimers Dement (N Y). 2022 Feb 23;8(1):e12262. doi: 10.1002/trc2.12262. eCollection 2022.
- Background: PubMed 36299611Assecondi S, Hu R, Kroeker J, Eskes G, Shapiro K. Older adults with lower working memory capacity benefit from transcranial direct current stimulation when combined with working memory training: A preliminary study. Front Aging Neurosci. 2022 Oct 10;14:1009262. doi: 10.3389/fnagi.2022.1009262. eCollection 2022.
- Background: PubMed 23978160Bottiroli S, Cavallini E, Dunlosky J, Vecchi T, Hertzog C. The importance of training strategy adaptation: a learner-oriented approach for improving older adults' memory and transfer. J Exp Psychol Appl. 2013 Sep;19(3):205-18. doi: 10.1037/a0034078. Epub 2013 Aug 26.
- Background: PubMed 22714020Grady C. The cognitive neuroscience of ageing. Nat Rev Neurosci. 2012 Jun 20;13(7):491-505. doi: 10.1038/nrn3256.
- Background: PubMed 12656297Kane MJ, Engle RW. Working-memory capacity and the control of attention: the contributions of goal neglect, response competition, and task set to Stroop interference. J Exp Psychol Gen. 2003 Mar;132(1):47-70. doi: 10.1037/0096-3445.132.1.47.
- Background: PubMed 20826313Lu H, Cheng PL, Lim BK, Khoshnevisrad N, Poo MM. Elevated BDNF after cocaine withdrawal facilitates LTP in medial prefrontal cortex by suppressing GABA inhibition. Neuron. 2010 Sep 9;67(5):821-33. doi: 10.1016/j.neuron.2010.08.012.
- Background: PubMed 12061414Park DC, Lautenschlager G, Hedden T, Davidson NS, Smith AD, Smith PK. Models of visuospatial and verbal memory across the adult life span. Psychol Aging. 2002 Jun;17(2):299-320.
- Background: PubMed 36460294Pergher V, Au J, Alizadeh Shalchy M, Santarnecchi E, Seitz A, Jaeggi SM, Battelli L. The benefits of simultaneous tDCS and working memory training on transfer outcomes: A systematic review and meta-analysis. Brain Stimul. 2022 Nov-Dec;15(6):1541-1551. doi: 10.1016/j.brs.2022.11.008. Epub 2022 Nov 29.
- Background: PubMed 19328449Reisberg B, Shulman MB. Commentary on "a roadmap for the prevention of dementia II: Leon Thal Symposium 2008." Subjective cognitive impairment as an antecedent of Alzheimer's dementia: policy import. Alzheimers Dement. 2009 Mar;5(2):154-6. doi: 10.1016/j.jalz.2009.01.011. No abstract available.
- Background: PubMed 36513642Ripp I, Emch M, Wu Q, Lizarraga A, Udale R, von Bastian CC, Koch K, Yakushev I. Adaptive working memory training does not produce transfer effects in cognition and neuroimaging. Transl Psychiatry. 2022 Dec 13;12(1):512. doi: 10.1038/s41398-022-02272-7.
- Background: PubMed 35493937Teixeira-Santos AC, Moreira CS, Pereira DR, Pinal D, Fregni F, Leite J, Carvalho S, Sampaio A. Working Memory Training Coupled With Transcranial Direct Current Stimulation in Older Adults: A Randomized Controlled Experiment. Front Aging Neurosci. 2022 Apr 12;14:827188. doi: 10.3389/fnagi.2022.827188. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Stefano Cappa, MD principal investigator
Dementia Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation in people with Cognitive Decline and Healthy Aging, run by IRCCS National Neurological Institute "C. Mondino" Foundation.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Bottiroli, Dc. (+39 0382 380201, sara.bottiroli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associative learning test scores (time frame: Immediately after the intervention program (T1).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929872, which also lists 11 linked publications.
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 3 Jul 2023.