An interventional study of rTMS and Sham rTMS in Mild Cognitive Impairment, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
This is an administrative supplement to an existing project "Using fMRI-guided TMS to increase central executive function in older adults: NCT02767323" This award allows extending our existing fMRI-TMS paradigm to patients with a prodromal form of Alzheimer's Disease (AD) known as amnestic Mild Cognitive Impairment (MCI), and investigate the role of brain health factors in mediating the TMS-related memory performance benefits associated with communication between a network of frontoparietal brain regions in these populations.
The focus on focal neurostimulation at only a single site represents a fundamental gap in the approach of memory-based neurostimulation therapies. Neurostimulation affects multiple sites within a cortical network, but these global effects have not been used as targets for stimulation because of limited knowledge about what influence these localized sites have on global changes in brain state. To address this problem, multimodal neuroimaging tools and network modeling approaches developed though the parent U01 project will be used, to demonstrate how focal neurostimulation improves the efficacy of TMS for enhancing memory function. These goals will be addressed in the Administrative Supplement under our two specific aims. First, network-guided TMS will be applied to optimize memory success based in the frontoparietal network (FPN) in a new group of MCI patients. A new form of TMS targeting that involves modeling of the global network to understand how the controllability of a stimulation site evokes changes in widespread brain networks will be tested. Second, structural and functional factors affecting the efficacy of individualized network-guided TMS will be identified to ameliorate deficits in MCI. By creating a multimodal model of neural deficits related to MCI, network-guided TMS will be adjusted to demonstrate how the MCI brain might compensate for these neural deficits. The parent U01 project has made foundational advances towards these goals, as we have demonstrated the ability of to selectively enhance and reduce working memory performance in healthy older adults. In the current Administrative Supplement this paradigm will be extended to a group of MCI participants in order to test the hypothesis that excitatory rTMS to the working memory network can provide positive outcomes for patients with pre-clinical AD. The proposed work will provide an important tool for studying the stability and controllability of network connectivity of memory states in the aging brain, as well as new information on the effectiveness of brain stimulation technologies as a therapeutic approach for cognitive decline.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 10 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
excitatory 5Hz rTMS will be applied over a node within the fronto-parietal network, defined via network analysis.
Device: rTMS
electrical sham coil applied over a node within the fronto-parietal network.
Device: Sham rTMS
excitatory 5Hz rTMS will be applied over the dorso-lateral prefrontal cortex showing the strongest fMRI activation.
Device: rTMS
electrical sham coil applied over the DLPFC.
Device: Sham rTMS
excitatory 5Hz rTMS will be used
an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Accuracy (in Percentage)
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS.
Time frame: Through study completion, an average of one year
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Reaction Times (ms)
Reaction times (in ms) will be assessed to evaluate the acute effect of rTMS
Time frame: Through study completion an average of one year
| Milestone | rTMS Over a Node Within the Fronto-parietal Network | Sham rTMS Over a Node Within the Fronto-parietal Network | rTMS Over the DLPFC | Sham rTMS Over the DLPFC |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS.
No measurements were reported for this outcome.
Reaction times (in ms) will be assessed to evaluate the acute effect of rTMS
No measurements were reported for this outcome.
Collected over adverse event data are collected during rTMS and a few minutes after.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rTMS Over a Node Within the Fronto-parietal Network | — | — | — |
| Sham rTMS Over a Node Within the Fronto-parietal Network | — | — | — |
| rTMS Over the DLPFC | — | — | — |
| Sham rTMS Over the DLPFC | — | — | — |
These participants only performed the behavioral task. No TMS was applied.
| Age, Categorical(Participants) | Enrolled Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 7 |
| Age, Continuous(years) | Enrolled Participants |
|---|---|
| Mean | 65.2 ± 6.6 |
| Sex: Female, Male(Participants) | Enrolled Participants |
|---|---|
| Female | 5 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Enrolled Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Enrolled Participants |
|---|---|
| United States | 10 |
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Plan to share: No
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Duke University