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NCT03584438 · ClinicalTrials.gov registry record · Early Phase 1
iTBS Methods and Motor Cortex Excitability
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT03584438: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT03584438 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03584438, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
In a recent publication by Gamboa et al. 20108 it was shown that extended theta-burst stimulation duration might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication. While the post treatment effects of the original Huang et al. 2005 protocol were successfully replicated, when continuous theta burst stimulation (cTBS) protocols were doubled to 1200 pulses over 80 seconds and the iTBS protocols were doubled to 1200 pulses over 390 seconds, there was increased facilitation after the prolonged cTBS and decreased excitability after prolonged iTBS. Currently there is an interest in optimizing repetitive transcranial magnetic stimulation (rTMS) protocols and in particular theta burst stimulation as both a therapeutic and an investigational tool. In Hanlon et al. 2015, a novel theta burst paradigm is described in which two trains of 1800 pulses of cTBS were administered, each train separated by a one-minute interval. In this study 11-cocaine dependent individuals underwent cTBS over the medial prefrontal cortex (MPFC) and showed attenuated craving as well as decreases in activity of the striatum and anterior insula. This study aims to replicate the findings of the Gamboa and Huang protocols as well as investigate how novel theta burst stimulation paradigms such as those described in Hanlon et al. 2015, which are currently being explored as therapeutic methods in addiction may change cortical excitability.
Primary Outcome
The excitability of the motor cortex may be modulated differently depending on the type of TBS protocol utilized. iTBS was originally described by Huang et al. 20057 resulting in an excitatory effects (LTP like) on the cortex. Gamboa et al. 20108 later confirmed this finding but showed that there was a decrease in excitability (LTD-like) when the protocol is doubled. Both of these protocols are to be replicated and in addition 2 new protocols. In order to investigate how cortical excitability ch
Interventions
- DEVICE Sham iTBS
- DEVICE Real iTBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-05-26 |
| Est. Completion | 2020-02-07 |
| Phase | Early Phase 1 |
What the finished NCT03584438 record still lists
NCT03584438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham iTBS is the first listed.
NCT03584438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03584438 about?
NCT03584438 is a clinical study titled "iTBS Methods and Motor Cortex Excitability". In a recent publication by Gamboa et al. 20108 it was shown that extended theta-burst stimulation duration might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication. While the post treatment effects of the original Huang et al. 2005 protocol were...
What is the current status of trial NCT03584438?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2018-05-26. Estimated completion is 2020-02-07.
What interventions are being tested in trial NCT03584438?
The interventions under investigation include: Sham iTBS (DEVICE), Real iTBS (DEVICE).
Who is sponsoring clinical trial NCT03584438?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03584438's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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