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Cognitive Enhancement in Healthy Elderly People (Pro-Cog)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997226
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Bar-Ilan University, Israel

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.


Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Transcranial Alternating Current Stimulation Device: tDCS or tACS over the left DLPFC with adaptive memory game Device: Sham tDCS or tACS over the left DLPFC with adaptive memory game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

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

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Cognitive Enhancement in Healthy Elderly People
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: tDCS over the left DLPFC with adaptive memory game
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
This intervention is described in arms 1 and 3.

Placebo Comparator: Sham tDCS over the left DLPFC with adaptive memory game
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
This intervention is described in arms 2 and 4.

Active Comparator: tACS over the left DLPFC at theta-gamma coupling with adaptive memory game
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
This intervention is described in arms 1 and 3.

Placebo Comparator: Sham tACS over the left DLPFC at theta-gamma coupling with adaptive memory game
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
This intervention is described in arms 2 and 4.




Primary Outcome Measures :
  1. Visual episodic memory of word pairs learning test (Marshall et al., 2004) [ Time Frame: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment ]
    Number of correctly recalled word pairs

  2. Ray auditory verbal learning test (episodic memory) includes immediate recall, and after time (Carlesimo et al., 1996), [ Time Frame: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment ]
    Number of correctly recalled items


Secondary Outcome Measures :
  1. Logical Memory Test 1 (Craft et al., 2000; Wechsler, 2008) [ Time Frame: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment ]
    Number of correctly recalled items

  2. Montreal questionnaire for Cognitive Assessment (MoCA, Nasreddine et al., 2005) [ Time Frame: Change from baseline (before treatment) to immediately after treatment (6 weeks) and 3 months after end of treatment ]
    Score at the MoCA test



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997226


Contacts
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Contact: Michal Lavidor, Prof. 0097235318171 michal.lavidor@gmail.com

Locations
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Israel
Department of Psychology Recruiting
Ramat Gan, Israel, 5290002
Contact: Shachar Ben Yizhak, MA       shacharbi330@gmail.com   
Sponsors and Collaborators
Bar-Ilan University, Israel
Investigators
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Principal Investigator: Michal Lavidor, Prof. Bar Ilan University
Publications of Results:

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Responsible Party: Bar-Ilan University, Israel
ClinicalTrials.gov Identifier: NCT04997226    
Other Study ID Numbers: 04102020
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will generate big data files due to 16 meetings with all 120 participants. There is not much point in sharing these mega-files, rather the investigators can share the final groups averages to measure memory change in the 4 experimental group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No