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NCT03309696 · ClinicalTrials.gov registry record · NA
Regulating Homeostatic Plasticity and the Physiological Response to rTMS
A NA study, sponsored by University of Arkansas.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03309696: Clinical Trial NA study, sponsored by University of Arkansas.
NCT03309696 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03309696, a NA study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This device-study includes a pilot, physiological investigation of normal human subjects. The aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry as measured by EEG recording. Currently, the application of non-invasive neuromodulation is rarely guided by detailed knowledge of how neural activity is altered in the brain circuits that are targeted for intervention. This gap in knowledge is problematic for interpreting response variability, which is common. To address this gap, the current proposal aims to combine two forms of neuromodulation sequentially, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at different frequencies of rTMS. Homeostatic plasticity, the initial activation state of a targeted circuit, is a key determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD) Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. We aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The protocol included an exploratory aim to examine physiological changes in patients with tinnitus but this aim was not part of the pilot physiological investigation and it could not be completed due to funding limitations.
Primary Outcome
TEPs refer to TMS-evoked EEG potentials. The P100 amplitude of TEPs is one means of assessing cortical excitability. The P100 amplitude has been shown to be a reliable metric in studies of healthy subjects. The P100 amplitude is used in this study to assess the excitation state of two regions of interest (ROIs), one in the TC and one in the DLPFC, at each period of TEP recording (i.e., Baseline, Post tDCS, Post rTMS, and 20 minute delay).
Interventions
- DEVICE sham tDCS and sham rTMS
- DEVICE sham tDCS and active rTMS
- DEVICE active tDCS and active rTMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
Why NCT03309696 stopped before completion
NCT03309696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which sham tDCS and sham rTMS is the first listed.
NCT03309696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03309696 about?
NCT03309696 is a clinical study titled "Regulating Homeostatic Plasticity and the Physiological Response to rTMS". This device-study includes a pilot, physiological investigation of normal human subjects. The aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry as measured by EEG recording. Currently, the application of non-invasive neuromodulation is rarely guided by deta...
What is the current status of trial NCT03309696?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2017-11-16. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT03309696?
The interventions under investigation include: sham tDCS and sham rTMS (DEVICE), sham tDCS and active rTMS (DEVICE), active tDCS and active rTMS (DEVICE).
Who is sponsoring clinical trial NCT03309696?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03309696's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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