Cognitive Enhancement in Healthy Elderly People

NCT04997226 | Unknown

• 1 other identifier: 04102020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

According to the European Commission Special Report, till 2030 it is expected ca. 40% increase of population aged 66-79. Increasing population of elderly people in modern society has suggested that more individuals are expected to suffer from cognitive deficits, as chronological aging is usually accompanied by declined cognition, in particular memory functions. The cognitive decline reaches medical attention for about 5-25% of the elderly population (over 65 years of age) as they suffer from Mild Cognitive Impairment (MCI). MCI is usually referred to as an intermediate phase between the expected cognitive decline of normal aging and the pathological cognitive decline linked to dementia. In recent years, a new viewpoint argues that substantial improvement in cognitive function may be possible even in older age, using appropriately designed training programs. In the current project the investigators propose a potential intervention that might delay the onset of dementia by maintaining cognitive performance in general and improving in MCI in particular. The current approach is to employ cognitive enhancement protocols, such as the combination of non-invasive, low intensity electrical stimulation and memory training aiming to preserve and ultimately improve cognitive abilities in MCI and healthy elderly.

Conditions

Transcranial Direct Current Stimulation; Transcranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (2)

• Visual episodic memory of word pairs learning test (Marshall et al., 2004)

  Number of correctly recalled word pairs

  Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment

• Ray auditory verbal learning test (episodic memory) includes immediate recall, and after time (Carlesimo et al., 1996),

  Number of correctly recalled items

  Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment

Secondary Outcomes (2)

• Logical Memory Test 1 (Craft et al., 2000; Wechsler, 2008)

  Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment

• Montreal questionnaire for Cognitive Assessment (MoCA, Nasreddine et al., 2005)

  Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment

Study Arms (4)

tDCS over the left DLPFC with adaptive memory game

ACTIVE COMPARATOR

The stimulation will be carried out using a battery-powered mobile device made by "Neurocon" with two 5 x 5 cm electrodes The anodal electrode will be positioned above the F3 region of a standard EEG cap that is parallel to the cortical DLPFC region. The return electrode will be placed over the right eyebrow. The electrodes will remain on the subjects head for 50 minutes - the entire duration of the session. 1mA stimulation will be given for 15 minutes, then a 20-minute break and again 15 minutes of 1 mA stimulation. This protocol has been shown to improve the duration of the stimulus effect (Monte-Silva et al., 2013).

Device: tDCS or tACS over the left DLPFC with adaptive memory game

Sham tDCS over the left DLPFC with adaptive memory game

PLACEBO COMPARATOR

As above but current will be operated for 1 minute - 30 seconds ramp up to 1 mA and 30 seconds ramp-down to initiate similar sensations to real stimulation. The electrodes will stay on the subjects heads for 50 minutes, similar to the active tDCS arm.

Device: Sham tDCS or tACS over the left DLPFC with adaptive memory game

tACS over the left DLPFC at theta-gamma coupling with adaptive memory game

ACTIVE COMPARATOR

As above but stimulation method will be employed at 2mA intensity for 20 minutes at theta-gamma coupling using a laplacian montage (Alekseichuk et al., 2016).

Device: tDCS or tACS over the left DLPFC with adaptive memory game

Sham tACS over the left DLPFC at theta-gamma coupling with adaptive memory game

PLACEBO COMPARATOR

As above but current will be operated for 1 minute - 30 seconds ramp up to 1 mA and 30 seconds ramp-down to initiate similar sensations to real stimulation. The electrodes will stay on the subjects heads for 20 minutes, similar to the active tACS arm.

Device: Sham tDCS or tACS over the left DLPFC with adaptive memory game

Interventions

tDCS or tACS over the left DLPFC with adaptive memory game DEVICE

This intervention is described in arms 1 and 3.

tACS over the left DLPFC at theta-gamma coupling with adaptive memory game; tDCS over the left DLPFC with adaptive memory game

Sham tDCS or tACS over the left DLPFC with adaptive memory game DEVICE

This intervention is described in arms 2 and 4.

Sham tACS over the left DLPFC at theta-gamma coupling with adaptive memory game; Sham tDCS over the left DLPFC with adaptive memory game

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal or corrected-to-normal vision good general health independent living MoCa score of at least 24 -

You may not qualify if:

• A history of acute or chronic neurological illness, heart disease, metabolic disorders, vascular disorders psychiatric disorder. epilepsy metal implants

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead

Study Sites (1)

Department of Psychology

Ramat Gan, 5290002, Israel

RECRUITING

Related Publications (18)

• Meiron O, Lavidor M. Prefrontal oscillatory stimulation modulates access to cognitive control references in retrospective metacognitive commentary. Clin Neurophysiol. 2014 Jan;125(1):77-82. doi: 10.1016/j.clinph.2013.06.013. Epub 2013 Jul 3.

  PMID: 23831184 RESULT

• Monte-Silva K, Kuo MF, Hessenthaler S, Fresnoza S, Liebetanz D, Paulus W, Nitsche MA. Induction of late LTP-like plasticity in the human motor cortex by repeated non-invasive brain stimulation. Brain Stimul. 2013 May;6(3):424-32. doi: 10.1016/j.brs.2012.04.011. Epub 2012 Jun 2.

  PMID: 22695026 RESULT

• Jacoby N, Lavidor M. Null tDCS Effects in a Sustained Attention Task: The Modulating Role of Learning. Front Psychol. 2018 Apr 6;9:476. doi: 10.3389/fpsyg.2018.00476. eCollection 2018.

  PMID: 29681876 RESULT

• Jacobson L, Koslowsky M, Lavidor M. tDCS polarity effects in motor and cognitive domains: a meta-analytical review. Exp Brain Res. 2012 Jan;216(1):1-10. doi: 10.1007/s00221-011-2891-9. Epub 2011 Oct 12.

  PMID: 21989847 RESULT

• Ditye T, Jacobson L, Walsh V, Lavidor M. Modulating behavioral inhibition by tDCS combined with cognitive training. Exp Brain Res. 2012 Jun;219(3):363-8. doi: 10.1007/s00221-012-3098-4. Epub 2012 Apr 25.

  PMID: 22532165 RESULT

• Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.

  PMID: 15324362 RESULT

• Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.

  PMID: 12425704 RESULT

• Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14.

  PMID: 27838936 RESULT

• Motter JN, Pimontel MA, Rindskopf D, Devanand DP, Doraiswamy PM, Sneed JR. Computerized cognitive training and functional recovery in major depressive disorder: A meta-analysis. J Affect Disord. 2016 Jan 1;189:184-91. doi: 10.1016/j.jad.2015.09.022. Epub 2015 Sep 26.

  PMID: 26437233 RESULT

• Park SH, Seo JH, Kim YH, Ko MH. Long-term effects of transcranial direct current stimulation combined with computer-assisted cognitive training in healthy older adults. Neuroreport. 2014 Jan 22;25(2):122-6. doi: 10.1097/WNR.0000000000000080.

  PMID: 24176927 RESULT

• Manenti R, Sandrini M, Brambilla M, Cotelli M. The optimal timing of stimulation to induce long-lasting positive effects on episodic memory in physiological aging. Behav Brain Res. 2016 Sep 15;311:81-86. doi: 10.1016/j.bbr.2016.05.028. Epub 2016 May 13.

  PMID: 27185737 RESULT

• Martin DM, Liu R, Alonzo A, Green M, Loo CK. Use of transcranial direct current stimulation (tDCS) to enhance cognitive training: effect of timing of stimulation. Exp Brain Res. 2014 Oct;232(10):3345-51. doi: 10.1007/s00221-014-4022-x. Epub 2014 Jul 4.

  PMID: 24992897 RESULT

• Andre S, Heinrich S, Kayser F, Menzler K, Kesselring J, Khader PH, Lefaucheur JP, Mylius V. At-home tDCS of the left dorsolateral prefrontal cortex improves visual short-term memory in mild vascular dementia. J Neurol Sci. 2016 Oct 15;369:185-190. doi: 10.1016/j.jns.2016.07.065. Epub 2016 Jul 30.

  PMID: 27653887 RESULT

• Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3.

  PMID: 20633376 RESULT

• Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.

  PMID: 17086200 RESULT

• Ambrus GG, Pisoni A, Primassin A, Turi Z, Paulus W, Antal A. Bi-frontal transcranial alternating current stimulation in the ripple range reduced overnight forgetting. Front Cell Neurosci. 2015 Sep 24;9:374. doi: 10.3389/fncel.2015.00374. eCollection 2015.

  PMID: 26441544 RESULT

• Campbell JI, Thompson VA. MorePower 6.0 for ANOVA with relational confidence intervals and Bayesian analysis. Behav Res Methods. 2012 Dec;44(4):1255-65. doi: 10.3758/s13428-012-0186-0.

  PMID: 22437511 RESULT

• Ben Izhak S, Jacoby N, Diedrich L, Antal A, Lavidor M. Enhanced cognitive performance in older adults through combined cognitive training and transcranial direct current stimulation. Sci Rep. 2025 Jul 6;15(1):24114. doi: 10.1038/s41598-025-08322-6.

  PMID: 40619473 DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Michal Lavidor, Prof.

  Bar Ilan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Lavidor, Prof.

CONTACT

0097235318171; michal.lavidor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are randomly assigned to one of the four groups and are not aware whether they receive sham or real stimulation. Data analysis will be conducted with analysts blind to the study condition.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will compare 4 intervention protocols aiming to improve memory performance: tDCS over the left DLPFC with adaptive memory game; Sham-tDCS with adaptive memory game; tACS over the left DLPFC at theta-gamma coupling with adaptive memory game; Sham tACS over the left DLPFC at theta-gamma coupling with adaptive memory game

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: September 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)