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NCT04010461 · ClinicalTrials.gov registry record · NA
Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
A NA study of Healthy, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT04010461: Completed NA study of Healthy, sponsored by University of Michigan.
NCT04010461 is a NA study of Healthy that has completed, run by University of Michigan. The registered enrollment target is 53 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04010461, a NA study of Healthy, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. This study will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated frontoparietal network (FPN), which subserves cognitive control - the ability to flexibly adapt and regulate behavior, an ability known to be impaired in neuropsychiatric conditions such as depression and dementia. Healthy volunteers that qualify for this study will have psychological assessments and cognitive measures (due to Covid, some of these were done via teleconference), as well as functional Magnetic Resonance Imaging (fMRI) scans, completed after administration of TMS. Participants will be asked to come in for a total of five visits that include; a screening and assessment visit; a baseline functional magnetic resonance imaging (fMRI) scan, followed by TMS session; Visits 3, 4, and 5 will be the experimental TMS session, followed by fMRI scan.
Primary Outcome
Fronto-parietal network (FPN) defined by BOLD change while subject performed the n-back working memory task, contrasting high (2-back) versus low (1-back) loads. Using the SPM12 package, data were normalized per standard, open source routines. Using a General Linear Model framework, a model was estimated with regressors (after convolution with hemodynamic response function) for 2-back \& 1-back conditions for each subject to predict BOLD change each day (arm).For analysis of group effects, secon
Conditions Studied
Interventions
- DEVICE TMS
- BEHAVIORAL n-back working memory task
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-11-11 |
| Est. Completion | 2022-03-29 |
| Phase | NA |
What the finished NCT04010461 record still lists
NCT04010461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which TMS is the first listed.
NCT04010461 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04010461 about?
NCT04010461 is a clinical study titled "Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State". The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be fac...
What is the current status of trial NCT04010461?
This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2019-11-11. Estimated completion is 2022-03-29.
What conditions does trial NCT04010461 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04010461?
The interventions under investigation include: TMS (DEVICE), n-back working memory task (BEHAVIORAL).
Who is sponsoring clinical trial NCT04010461?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04010461 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04010461's enrollment target sits among peer trials
53 439th of 1090 higher than 651 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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