MotivationNCT04268186
TDCS to Improve Motivation and Memory in Elderly (TIME)
A study testing Direct tDCS, Indirect tDCS and Personalized tDCS in people with Motivation, run by Northeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation
- What is being tested?
- Direct tDCS, Indirect tDCS and Personalized tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- between the ages of 65 and 80
- normal or corrected to normal vision
- fluent in speaking, reading and understanding English
- right-handed
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Alexandra Touroutoglou, PhD contact
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Sumientra M Rampersad, PhD, 617-373-3880, s.rampersad@northeastern.edu
About this study
Official title: 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.
- Conditions
- Motivation
- Being tested
- Direct tDCS, Indirect tDCS, Personalized tDCS, Sham tDCS
- Keywords
- cognitive functioning, elderly, healthy, tDCS, motivation, memory, structural MRI, resting-state fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct tDCSDevice
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.
Indirect tDCSDevice
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.
Personalized tDCSDevice
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Direct tDCS | Experimental | Transcranial direct current stimulation (tDCS) was computationally optimized to target mid-cingulate cortex directly. Receives: 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. Receives: 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. Receives: Device: Personalized tDCS |
| Sham tDCS | Sham comparator | Placebo transcranial direct current stimulation (tDCS) will be applied. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week
Change in "Time to complete unsolvable anagrams" from baseline
Time in seconds participants spend on unsolvable anagram task before quitting.
Measured: 1 week
Secondary outcomes (3)
Change in "Memory recognition discriminability (d')" from baseline
A standard measure of memory recognition performance in an associative memory task.
Measured: 1 week
Change in "Intrinsic functional connectivity strength" from baseline
A measure of the strength with which mid-cingulate cortex and other brain regions are functionally connected, as measured with resting-state fMRI.
Measured: 1 week
Change in "California Verbal Learning Test" score from baseline
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start22 Jan 2020
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sumientra Rampersad, Northeastern University
- Investigators
- Sumientra M Rampersad, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268186
- Sponsor's protocol ID
- 18-07-20
- Other IDs
- R21AG061743
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified connectivity maps and motivation and memory task data will be made available via our lab website.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation as a Tool to Study the Role of Motivation in Age-related Cognitive Abilities
- ClinicalTrials.gov ID
- NCT04268186
- Acronym / sponsor ID
- 18-07-20
- Conditions
- Motivation
- Keywords
- cognitive functioning, elderly, healthy, tDCS, motivation, memory, structural MRI, resting-state fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute on Aging (NIA)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct tDCS | Experimental | Device: Direct tDCSTranscranial direct current stimulation (tDCS) was computationally optimized to target mid-cingulate cortex directly. |
| Indirect tDCS | Experimental | Device: Indirect tDCSTranscranial direct current stimulation (tDCS) was computationally optimized to target the middle frontal gyrus, a brain area connected to mid-cingulate cortex. |
| Personalized tDCS | Experimental | Device: Personalized tDCSTranscranial 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. |
| Sham tDCS | Sham comparator | Device: Sham tDCSPlacebo transcranial direct current stimulation (tDCS) will be applied. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- between the ages of 65 and 80
- normal or corrected to normal vision
- fluent in speaking, reading and understanding English
- right-handed
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct tDCSTranscranial 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. | Device | Direct tDCS |
| Indirect tDCSTranscranial 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. | Device | Indirect tDCS |
| Personalized tDCSTranscranial 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. | Device | Personalized tDCS |
| Sham tDCSTranscranial 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. | Device | Sham tDCS |
Primary outcome
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.
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.
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.
Change in "Time to complete unsolvable anagrams" from baseline
Time frame: 1 week
Time in seconds participants spend on unsolvable anagram task before quitting.
3 secondary outcomes
Change in "Memory recognition discriminability (d')" from baseline
Time frame: 1 week
Change in "Intrinsic functional connectivity strength" from baseline
Time frame: 1 week
Change in "California Verbal Learning Test" score from baseline
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Yes. De-identified connectivity maps and motivation and memory task data will be made available via our lab website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Touroutoglou, PhD contact
Sumientra M Rampersad, PhD principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct tDCS, Indirect tDCS and Personalized tDCS in people with Motivation, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sumientra M Rampersad, PhD (6173733880, s.rampersad@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Feeling of difficulty" from baseline (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.