Mild Cognitive ImpairmentTMS-ADNCT05460468
Neuromodulation of Memory in Aging
A study testing Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment and MCI, run by Indiana University at 1 site in United States.
Trial summary
The proposed research will use closed-loop transcranial magnetic stimulation (TMS) based on individualized brain networks to establish parameters that can reliably control brain states. This will be tested in healthy aging and mild cognitive impairment (MCI) cohorts. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, MCI
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking
- Willing to provide consent
Who cannot join
- History of any Axis I DSM-V disorder, excluding major depressive disorder or generalized anxiety disorders
- Current history of substance abuse or dependence (excluding nicotine)
- Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus Nerve stimulation device
- Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
- Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, Dementia, Hungtington chorea; Multiple Sclerosis.
- Current use of medications known to lower the seizure threshold and/or affect working memory
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Simon Davis, PhD, 9196680437, simon.davis@duke.edu
Emily Finch, BS, 9196682299, emily.finch@duke.edu
About this study
Official title: Adaptive Neuromodulation of Working Memory Networks in Aging and Dementia
The proposed research will use closed-loop transcranial magnetic stimulation (TMS) based on individualized brain networks to establish parameters that can reliably control brain states. This will be tested in healthy aging and mild cognitive impairment (MCI) cohorts. The investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory and then target this network using closed-loop TMS to the Prefrontal Cortex. Investigators will measure the impact of TMS on working memory performance and task-based neural activity. The project will use brain stimulation and network modeling techniques to enhance working memory in healthy older adults and MCI and will demonstrate the value of closed-loop, network-guided TMS for future clinical applications.
Read the detailed description
Dementia due to Alzheimer's disease (AD) is a leading public health concern in the US with enormous care costs and no effective pharmacotherapy despite multiple clinical trials. Multiple studies have shown mild cognitive impairment (MCI) to be a precursor risk for AD and to be more amenable to intervention. While preclinical studies have shown that directly modulating activity in the prefrontal cortex (PFC) using non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), can modulate cognitive function in healthy older adults, there is little evidence of reliable efficacy in MCI.
The investigators posit three reasons for this lack of efficacy. First, there is no established means of estimating a reliable biomarker and unique dose-response relationship between TMS intensity and brain activity. Second, standard TMS protocols fail to capture the dynamic nature of cognitive states and the reaction of endogenous brain states to exogenous neuromodulation. Third, no studies using TMS in AD-related populations have accounted for the influence of cerebrovascular disease in the response to TMS. The investigators propose to address these shortcomings by using closed-loop TMS, based on individualized brain networks to establish parameters that can reliably control brain states during normal memory functioning in healthy aging and MCI.
To achieve this goal, the investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory (WM), a cognition function with a reliable prefrontal cortex (PFC) network characterization. The investigators will then target this network using closed-loop TMS to the PFC and measure the impact on WM performance and task-based neural activity. This approach uses concurrent TMS-fMRI to identify dose-response relationships in the working memory network. Next, the investigators apply novel closed-loop TMS to perturb this network using temporally-precise TMS-EEG. Lastly, the investigators will integrate information collected via fMRI and EEG into a single computational framework to model spatiotemporal dynamics of the global brain network and predict the success of the TMS-related response in our MCI cohort. The project will use cutting-edge brain stimulation and network modeling techniques to enhance WM in healthy older adults and MCI and will provide a demonstration of the value of closed-loop, network-guided TMS for future clinical applications.
- Conditions
- Mild Cognitive Impairment, MCI
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- TMS, Transcranial Magnetic Stimulation, Memory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS rTMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve a variety of cognitive conditions, and to probe the dynamics of normal brain function.
| Study group | Role | What they receive |
|---|---|---|
| TMS-Randomized | Experimental | Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the first condition, arrhythmic TMS trains with a stochastic (randomized) inter-pulse interval, will be used to disrupt cortical alpha oscillations and thus be expected to enhance memory performance. Receives: Device: Transcranial Magnetic Stimulation |
| TMS-Ordered | Experimental | Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the second condition, rhythmic (ordered) alpha-frequency TMS trains, with the expectation that this alpha stimulation will further entrain a synchronization during the task and thereby worsen memory performance. Receives: Device: Transcranial Magnetic Stimulation |
| TMS-Sham | Sham comparator | Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In a third condition, sham stimulation will be delivered at the same randomized inter-pulse interval, but with no TMS delivered to the brain. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory Task
The difference in memory accuracy between TMS conditions (random vs. ordered vs. sham stimulation) on a working memory task. Each trial of the task consists of stimulus presentation of an array of letters, a delay period in which subjects alphabetize the letters, and probe period where subjects indicate whether the number corresponds to the alphabetized position of the letter probe presented. Memory is subsequently assessed as a function of TMS condition.
Measured: Collected during TMS-EEG (Day 4)
Functional network connectivity
Functional network connectivity/activity is estimated by comparing the hemodynamic time courses of two or more regions of the brain. The correlation between the time courses of each pair of regions is termed functional network connectivity. The Working Memory Network (WMN) is identified by comparing fMRI-based functional network connectivity for high vs low working memory load (e.g., remembering 4 versus 3 items).
Measured: Collected during the initial neuroimaging session (Day 2)
Vascular density (VAD)
This measure of neurovascular brain health, vascular density (VAD), as estimated by an automated method of segmenting veins with a magnetic resonance imaging (MRI) sequence known as susceptibility weighted imaging. This measure can be used to estimate the dilation of cerebral veins, and therefore VAD.
Measured: Collected during the second neuroimaging session (Day 3)
EEG-based connectivity
EEG data will be source reconstructed to a fine-grained grid and timecourses of the solution points are averaged per region and per subject. The imaginary part of the coherence (iCoh) of averaged EEG source signals will be assessed within the alpha and theta frequency bands to build EEG-based connectivity matrices ("connectomes") for alpha- and theta-based connectivity, for each subject.
Measured: Collected during TMS-EEG (Day 4)
Secondary outcomes (7)
Montreal Cognitive Assessment (MoCA)
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. This widespread tool is used to assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The principle outcome measure is a summary score combining performance on each subtest. Scores range from 0 to 30. A higher score indicates intact cognitive functions.
Measured: Collected during the initial screening visit (Day 1)
National Institutes of Health (NIH) Toolbox Cognitive Battery
The primary outcome measure of the NIH Toolbox is a Crystallized or Fluid Intelligence score. Fluid intelligence involves comprehension, reasoning and problem solving, while crystallized intelligence involves recalling stored knowledge and past experiences. These scores are normalized and scaled to reflect a 1-100 range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Hopkins Verbal Learning Test (HVLT-2)
The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). These scores are normalized to reflect a 1-100 percentile range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Brief Visuospatial Memory Test (BVMT-R)
The BVMT-R is a commonly used assessment tool to measure visuospatial learning and memory. A visual display of six simple figures arranged in a 2 × 3 matrix is shown to participants for three consecutive 10-second trials. Scoring of the immediate and delayed recall as well as copy trials are based on the accuracy of the drawings and the location of the figures. These scores are normalized to reflect a 1-100 percentile range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Number Span Forwards/ Backwards
Span tests measure the ability of a subject to remember a series of numbers in forward or reverse order. These scores are normalized to reflect a 1-100 percentile range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Category & Phonemic Verbal Fluency
Fluency tests measure the participant's ability to generate new exemplars for each categorical (e.g., farm animals) or phonemic (e.g., words starting with "b") prompts. The number of exemplars generated is recorded as the primary outcome for this test. These scores are normalized to reflect a 1-100 percentile range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Trail Making Test
The purpose of the "Trails" test is to gauge the ability of the participant to trace paths between a series of letters and numbers on a sheet of paper, and can provide insights into a person's cognitive function based on how fast they can search, scan, and process visual information. These scores are normalized to reflect a 1-100 percentile range. Higher scores indicate better performance.
Measured: Collected during the initial screening visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start28 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The study has three Aims and thus three models. For Aim 1, the primary outcome measure is fMRI BOLD. Researchers will estimate the dose-response relationship between TMS intensity and BOLD response in two cortical sites for response to TMS. For Aim 2 the primary outcome measure is impact of closed-loop TMS treatment on working memory task performance. For Aim 3, the primary outcome measure is the strength of mediation of brain health (e.g., vascular density) predictors of cognition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Simon W. Davis, Indiana University
- Investigators
- Simon W Davis, PhD, Principal investigator, Duke UniversityAndy Liu, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460468
- Sponsor's protocol ID
- 27820
- Acronym
- TMS-AD
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Neuromodulation of Working Memory Networks in Aging and Dementia
- ClinicalTrials.gov ID
- NCT05460468
- Acronym / sponsor ID
- TMS-AD / 27820
- Conditions
- Mild Cognitive Impairment, MCI
- Keywords
- TMS, Transcranial Magnetic Stimulation, Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jul 2022 (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.
The proposed research will use closed-loop transcranial magnetic stimulation (TMS) based on individualized brain networks to establish parameters that can reliably control brain states. This will be tested in healthy aging and mild cognitive impairment (MCI) cohorts. The investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory and then target this network using closed-loop TMS to the Prefrontal Cortex. Investigators will measure the impact of TMS on working memory performance and task-based neural activity. The project will use brain stimulation and network modeling techniques to enhance working memory in healthy older adults and MCI and will demonstrate the value of closed-loop, network-guided TMS for future clinical applications.
Detailed description
Dementia due to Alzheimer's disease (AD) is a leading public health concern in the US with enormous care costs and no effective pharmacotherapy despite multiple clinical trials. Multiple studies have shown mild cognitive impairment (MCI) to be a precursor risk for AD and to be more amenable to intervention. While preclinical studies have shown that directly modulating activity in the prefrontal cortex (PFC) using non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), can modulate cognitive function in healthy older adults, there is little evidence of reliable efficacy in MCI.
The investigators posit three reasons for this lack of efficacy. First, there is no established means of estimating a reliable biomarker and unique dose-response relationship between TMS intensity and brain activity. Second, standard TMS protocols fail to capture the dynamic nature of cognitive states and the reaction of endogenous brain states to exogenous neuromodulation. Third, no studies using TMS in AD-related populations have accounted for the influence of cerebrovascular disease in the response to TMS. The investigators propose to address these shortcomings by using closed-loop TMS, based on individualized brain networks to establish parameters that can reliably control brain states during normal memory functioning in healthy aging and MCI.
To achieve this goal, the investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory (WM), a cognition function with a reliable prefrontal cortex (PFC) network characterization. The investigators will then target this network using closed-loop TMS to the PFC and measure the impact on WM performance and task-based neural activity. This approach uses concurrent TMS-fMRI to identify dose-response relationships in the working memory network. Next, the investigators apply novel closed-loop TMS to perturb this network using temporally-precise TMS-EEG. Lastly, the investigators will integrate information collected via fMRI and EEG into a single computational framework to model spatiotemporal dynamics of the global brain network and predict the success of the TMS-related response in our MCI cohort. The project will use cutting-edge brain stimulation and network modeling techniques to enhance WM in healthy older adults and MCI and will provide a demonstration of the value of closed-loop, network-guided TMS for future clinical applications.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study has three Aims and thus three models. For Aim 1, the primary outcome measure is fMRI BOLD. Researchers will estimate the dose-response relationship between TMS intensity and BOLD response in two cortical sites for response to TMS. For Aim 2 the primary outcome measure is impact of closed-loop TMS treatment on working memory task performance. For Aim 3, the primary outcome measure is the strength of mediation of brain health (e.g., vascular density) predictors of cognition.
| Arm | Type | Receives |
|---|---|---|
| TMS-Randomized | Experimental | Device: Transcranial Magnetic StimulationThree different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the first condition, arrhythmic TMS trains with a stochastic (randomized) inter-pulse interval, will be used to disrupt cortical alpha oscillations and thus be expected to enhance memory performance. |
| TMS-Ordered | Experimental | Device: Transcranial Magnetic StimulationThree different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the second condition, rhythmic (ordered) alpha-frequency TMS trains, with the expectation that this alpha stimulation will further entrain a synchronization during the task and thereby worsen memory performance. |
| TMS-Sham | Sham comparator | Device: Transcranial Magnetic StimulationThree different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In a third condition, sham stimulation will be delivered at the same randomized inter-pulse interval, but with no TMS delivered to the brain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English Speaking
- Willing to provide consent
Key exclusion criteria (6 listed)
- History of any Axis I DSM-V disorder, excluding major depressive disorder or generalized anxiety disorders
- Current history of substance abuse or dependence (excluding nicotine)
- Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus Nerve stimulation device
- Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
- Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, Dementia, Hungtington chorea; Multiple Sclerosis.
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMS rTMSTranscranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve a variety of cognitive conditions, and to probe the dynamics of normal brain function. | Device | TMS-Ordered, TMS-Randomized, TMS-Sham |
Primary outcome
Working Memory Task
Time frame: Collected during TMS-EEG (Day 4)
The difference in memory accuracy between TMS conditions (random vs. ordered vs. sham stimulation) on a working memory task. Each trial of the task consists of stimulus presentation of an array of letters, a delay period in which subjects alphabetize the letters, and probe period where subjects indicate whether the number corresponds to the alphabetized position of the letter probe presented. Memory is subsequently assessed as a function of TMS condition.
Functional network connectivity
Time frame: Collected during the initial neuroimaging session (Day 2)
Functional network connectivity/activity is estimated by comparing the hemodynamic time courses of two or more regions of the brain. The correlation between the time courses of each pair of regions is termed functional network connectivity. The Working Memory Network (WMN) is identified by comparing fMRI-based functional network connectivity for high vs low working memory load (e.g., remembering 4 versus 3 items).
Vascular density (VAD)
Time frame: Collected during the second neuroimaging session (Day 3)
This measure of neurovascular brain health, vascular density (VAD), as estimated by an automated method of segmenting veins with a magnetic resonance imaging (MRI) sequence known as susceptibility weighted imaging. This measure can be used to estimate the dilation of cerebral veins, and therefore VAD.
EEG-based connectivity
Time frame: Collected during TMS-EEG (Day 4)
EEG data will be source reconstructed to a fine-grained grid and timecourses of the solution points are averaged per region and per subject. The imaginary part of the coherence (iCoh) of averaged EEG source signals will be assessed within the alpha and theta frequency bands to build EEG-based connectivity matrices ("connectomes") for alpha- and theta-based connectivity, for each subject.
7 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: Collected during the initial screening visit (Day 1)
National Institutes of Health (NIH) Toolbox Cognitive Battery
Time frame: Collected during the initial screening visit (Day 1)
Hopkins Verbal Learning Test (HVLT-2)
Time frame: Collected during the initial screening visit (Day 1)
Brief Visuospatial Memory Test (BVMT-R)
Time frame: Collected during the initial screening visit (Day 1)
Number Span Forwards/ Backwards
Time frame: Collected during the initial screening visit (Day 1)
Category & Phonemic Verbal Fluency
Time frame: Collected during the initial screening visit (Day 1)
Trail Making Test
Time frame: Collected during the initial screening visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Simon W Davis, PhD principal investigator
Duke University
Andy Liu, MD principal investigator
Duke 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 Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment and MCI, run by Indiana 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon W Davis, PhD (9196841243, simon.davis@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory Task (time frame: Collected during TMS-EEG (Day 4)). 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 11 Aug 2026.