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TDCS to Improve Motivation and Memory in Elderly (TIME)

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: NCT04268186
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Sumientra Rampersad, Northeastern University

Brief Summary:
Fundamental advancements in understanding successful aging are limited by the lack of causal, rather than just correlational methods to connect age-related changes in memory ability to changes in brain structure and function. In this study, non-invasive electric brain stimulation will be used as a tool to create causal links between successful memory function in aging and brain structures associated with motivation. Recently, it was shown that a group of elderly, dubbed "superagers", are indistinguishable from young adults in memory performance and the structure of cortical limbic regions. A key superaging region is mid-cingulate cortex (MCC), a brain structure associated with motivation and tenacity. The MCC is a hub region that synchronizes information flow between three core brain networks. The goal of the research is to explore the contribution of motivation to memory performance by modulating MCC connectivity with transcranial direct current stimulation (tDCS) to provide the first causal evidence that experimentally induced motivation can improve memory performance. Since MCC has not been stimulated with tDCS before, we will test three different stimulation protocols and compare against a placebo. The stimulation protocols were computationally optimized for this project. The primary aim is to find the stimulation protocol most successful at improving memory performance. In order to elucidate the mechanisms behind these changes, effects of stimulation on motivation and network connectivity will be investigated. If indeed memory can be improved by increasing motivation and effort via stimulating MCC, this study will generate new insights into the motivational mechanisms of successful aging.

Condition or disease Intervention/treatment Phase
Motivation Device: Direct tDCS Device: Indirect tDCS Device: Personalized tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Noninvasive Brain Stimulation as a Tool to Study the Role of Motivation in Age-related Cognitive Abilities
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Direct tDCS
Transcranial direct current stimulation (tDCS) was computationally optimized to target mid-cingulate cortex directly.
Device: Direct tDCS
Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used is two electrodes at AFz and CPz of the 10-10 electrode system.

Experimental: Indirect tDCS
Transcranial direct current stimulation (tDCS) was computationally optimized to target the middle frontal gyrus, a brain area connected to mid-cingulate cortex.
Device: Indirect tDCS
Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used is two electrodes at AF3 and AF4 of the 10-10 electrode system.

Experimental: Personalized tDCS
Transcranial direct current stimulation (tDCS) will be individually optimized to simultaneously stimulate key nodes connected to mid-cingulate cortex, including anterior insula, MFG and supramarginal gyrus.
Device: Personalized tDCS
Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used will be optimized to stimulate key nodes connected to MCC, including anterior insula, MFG and supramarginal gyrus, and designed using an individual head model that will be combined with each subject's measured connectivity map. The number of electrodes will be minimally 2 and maximally 32.

Sham Comparator: Sham tDCS
Placebo transcranial direct current stimulation (tDCS) will be applied.
Device: Sham tDCS
Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. Placebo stimulation will be applied by ramping the current up and immediately down over 30 seconds. The configuration used is two electrodes at AF3 and AF4 of the 10-10 electrode system.




Primary Outcome Measures :
  1. Change in "Feeling of difficulty" from baseline [ Time Frame: 1 week ]
    Self-reports of difficulty will be queried during a memory task. Feeling of difficulty asks "How easy or difficult do you think the task will be (did you find the task)?" Answer is reported on a 7 point-scale.

  2. Change in "Estimates of effort" from baseline [ Time Frame: 1 week ]
    Self-reports of effort will be queried during a memory task. Estimates of Effort asks "How much effort do you think it will take you (did it take you) to complete the task?" Answer is reported on a 7 point-scale.

  3. Change in "NASA Task Load Index" from baseline [ Time Frame: 1 week ]
    NASA Task Load Index will be queried during a memory task. It includes self-report scales that provide state markers of cognitive effort.

  4. Change in "Time to complete unsolvable anagrams" from baseline [ Time Frame: 1 week ]
    Time in seconds participants spend on unsolvable anagram task before quitting.


Secondary Outcome Measures :
  1. Change in "Memory recognition discriminability (d')" from baseline [ Time Frame: 1 week ]
    A standard measure of memory recognition performance in an associative memory task.

  2. Change in "Intrinsic functional connectivity strength" from baseline [ Time Frame: 1 week ]
    A measure of the strength with which mid-cingulate cortex and other brain regions are functionally connected, as measured with resting-state fMRI.

  3. Change in "California Verbal Learning Test" score from baseline [ Time Frame: 1 week ]
    California Verbal Learning Test (CVLT-II) is a comprehensive, detailed assessment of verbal learning and memory deficits in older adolescents and adults. The task asks participants to remember a list of 16 words. Higher scores mean better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between the ages of 65 and 80
  • normal or corrected to normal vision
  • fluent in speaking, reading and understanding English
  • right-handed

Exclusion Criteria:

  • any metal implants that may cause harm through MRI scanning
  • other metals that may interfere with obtaining MRI signals
  • claustrophobic
  • pregnancy
  • history of neurological or psychiatric illnesses
  • history of fainting, seizures or epilepsy
  • history of migraines
  • history of drug abuse
  • learning disability
  • intracranial lesion
  • any prescription or regular medication except for birth control
  • any uncontrolled medical condition
  • skin disease or damage on scalp
  • hair style or head dress that prevents electrode contact with the scalp
  • any condition affecting agility of hands (e.g. acute or chronic tenosynovitis, active joint deformity of arthritic origin)

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): NCT04268186


Contacts
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Contact: Sumientra M Rampersad, PhD 6173733880 s.rampersad@northeastern.edu
Contact: Alexandra Touroutoglou, PhD atourout@nmr.mgh.harvard.edu

Locations
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United States, Massachusetts
Northeastern University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sumientra M Rampersad, PhD    617-373-3880    s.rampersad@northeastern.edu   
Sponsors and Collaborators
Northeastern University
Massachusetts General Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Sumientra M Rampersad, PhD Northeastern University

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Responsible Party: Sumientra Rampersad, Research Assistant Professor, Northeastern University
ClinicalTrials.gov Identifier: NCT04268186    
Other Study ID Numbers: 18-07-20
R21AG061743 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified connectivity maps and motivation and memory task data will be made available via our lab website.
Time Frame: Data will be made available within 6 months after publication.
Access Criteria: Data will be freely available on our lab website.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sumientra Rampersad, Northeastern University:
cognitive functioning
elderly
healthy
tDCS
motivation
memory
structural MRI
resting-state fMRI