- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268186
TDCS to Improve Motivation and Memory in Elderly (TIME)
February 11, 2020 updated by: Sumientra Rampersad, Northeastern University
Noninvasive Brain Stimulation as a Tool to Study the Role of Motivation in Age-related Cognitive Abilities
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sumientra M Rampersad, PhD
- Phone Number: 6173733880
- Email: s.rampersad@northeastern.edu
Study Contact Backup
- Name: Alexandra Touroutoglou, PhD
- Email: atourout@nmr.mgh.harvard.edu
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Contact:
- Sumientra M Rampersad, PhD
- Phone Number: 617-373-3880
- Email: s.rampersad@northeastern.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Direct tDCS
Transcranial direct current stimulation (tDCS) was computationally optimized to target mid-cingulate cortex directly.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
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.
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1 week
|
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.
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1 week
|
Change in "Time to complete unsolvable anagrams" from baseline
Time Frame: 1 week
|
Time in seconds participants spend on unsolvable anagram task before quitting.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in "Memory recognition discriminability (d')" from baseline
Time Frame: 1 week
|
A standard measure of memory recognition performance in an associative memory task.
|
1 week
|
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.
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1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sumientra M Rampersad, PhD, Northeastern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 22, 2020
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 11, 2020
First Posted (ACTUAL)
February 13, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-07-20
- R21AG061743 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified connectivity maps and motivation and memory task data will be made available via our lab website.
IPD Sharing Time Frame
Data will be made available within 6 months after publication.
IPD Sharing Access Criteria
Data will be freely available on our lab website.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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