Non-invasive Brain Stimulation and Strategic Memory Training

NCT05929872 | Not Yet Recruiting

• 1 other identifier: StMe-tDCS2023
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cognitive Decline; Healthy Aging

Keywords

Healthy aging; Subjective cognitive decline; Non-pharmacological treatments; Memory training; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (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

  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

  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

  3 months (T3) after the end of the intervention program.

Secondary Outcomes (15)

• List learning tests scores

  Immediately after the intervention program (T1).

• List learning tests scores

  1 month (T2) after the end of the intervention program.

• List learning tests scores

  3 months (T3) after the end of the intervention program.

• Name-face learning test scores

  Immediately after the intervention program (T1).

• Name-face learning test scores

  1 month (T2) after the end of the intervention program.

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group receives strategic memory training plus non-invasive brain stimulation (ACTIVE tDCS).

Other: Non-invasive brain stimulation

Control Group

SHAM COMPARATOR

The control group receives strategic memory training plus sham non-invasive brain stimulation (SHAM tDCS).

Other: Sham non-invasive brain stimulation

Interventions

Non-invasive brain stimulation OTHER

ACTIVE transcranial direct current stimulation( tDCS)

Experimental group

Sham non-invasive brain stimulation OTHER

SHAM tDCS

Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• MMSE ≥ 24.
• GDS \< e uguale 11.
• Age between 65 and 85 years.
• Educational level ≥ 5 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• University of Pavia: collaborator

Related Publications (11)

• 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.

  PMID: 35229023 BACKGROUND

• Assecondi 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.

  PMID: 36299611 BACKGROUND

• Bottiroli 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.

  PMID: 23978160 BACKGROUND

• Grady C. The cognitive neuroscience of ageing. Nat Rev Neurosci. 2012 Jun 20;13(7):491-505. doi: 10.1038/nrn3256.

  PMID: 22714020 BACKGROUND

• Kane 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.

  PMID: 12656297 BACKGROUND

• Lu 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.

  PMID: 20826313 BACKGROUND

• Park 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.

  PMID: 12061414 BACKGROUND

• Pergher 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.

  PMID: 36460294 BACKGROUND

• Reisberg 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.

  PMID: 19328449 BACKGROUND

• Ripp 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.

  PMID: 36513642 BACKGROUND

• Teixeira-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.

  PMID: 35493937 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stefano Cappa, MD

  Dementia Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Bottiroli, Dc.

CONTACT

+39 0382 380201; sara.bottiroli@unipv.it

Cinzia Fattore, MD

CONTACT

+39 0382 380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, double-blind, randomized controlled study

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 3, 2023
• Study Start: July 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share