NCT04268186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 10, 2020

Last Update Submit

February 11, 2020

Conditions

Keywords

cognitive functioningelderlyhealthytDCSmotivationmemorystructural MRIresting-state fMRI

Outcome Measures

Primary Outcomes (4)

  • Change in "Feeling of difficulty" from baseline

    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.

    1 week

  • Change in "Estimates of effort" from baseline

    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.

    1 week

  • Change in "NASA Task Load Index" from baseline

    NASA Task Load Index will be queried during a memory task. It includes self-report scales that provide state markers of cognitive effort.

    1 week

  • Change in "Time to complete unsolvable anagrams" from baseline

    Time in seconds participants spend on unsolvable anagram task before quitting.

    1 week

Secondary Outcomes (3)

  • Change in "Memory recognition discriminability (d')" from baseline

    1 week

  • Change in "Intrinsic functional connectivity strength" from baseline

    1 week

  • Change in "California Verbal Learning Test" score from baseline

    1 week

Study Arms (4)

Direct tDCS

EXPERIMENTAL

Transcranial direct current stimulation (tDCS) was computationally optimized to target mid-cingulate cortex directly.

Device: Direct tDCS

Indirect tDCS

EXPERIMENTAL

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

Personalized tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

Placebo transcranial direct current stimulation (tDCS) will be applied.

Device: Sham tDCS

Interventions

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.

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 AF3 and AF4 of the 10-10 electrode system.

Indirect 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.

Personalized tDCS
Sham tDCSDEVICE

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.

Sham tDCS

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Sumientra M Rampersad, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumientra M Rampersad, PhD

CONTACT

Alexandra Touroutoglou, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 13, 2020

Study Start

January 22, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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.

Locations