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NCT03373162 · ClinicalTrials.gov registry record · Phase 4
Functional Effects of Botox on the Brain Using MRS and fMRI
A Phase 4 study of Healthy, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03373162: Completed Phase 4 study of Healthy, sponsored by University of California, Irvine.
NCT03373162 is a Phase 4 study of Healthy that has completed, run by University of California, Irvine. The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03373162, a Phase 4 study of Healthy, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g., bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014). Recently, several studies have suggested that peripheral BOTOX injections in the region of the glabellar lines (muscles around the eyes) may be effective in treating major depression and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX injections on the brain is not well understood. Therefore, the Investigators propose to further explore the functional effects of BOTOX injections on brain in healthy controls. The approach will involve the measurement of brain metabolites in the brainstem using MRS as well as an investigation of the functioning and connectivity between regions of the brain using resting state MRI and high resolution fMRI.
Primary Outcome
Determine whether there are metabolic differences in the brain stem in healthy individuals as a result of BOTOX using MRS. Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Metabolite FIDs were averaged within each task and processed using TARQUIN (v.4.3.6) software for spectral fitting. The acquired MRS spectra was corrected for tissue type and T2 relaxation differences. Using
Conditions Studied
Interventions
- DRUG onabotulinumtoxinA
Study Locations (1)
California
- University of California, Irvine - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-30 |
| Est. Completion | 2018-03-16 |
| Phase | Phase 4 |
What the finished NCT03373162 record still lists
NCT03373162 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which onabotulinumtoxinA is the first listed.
NCT03373162 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03373162 about?
NCT03373162 is a clinical study titled "Functional Effects of Botox on the Brain Using MRS and fMRI". The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in a growing number of indications including disorders involving skeletal muscle (e.g., strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g., bladder), glands (axillary hyper...
What is the current status of trial NCT03373162?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2017-09-30. Estimated completion is 2018-03-16.
What conditions does trial NCT03373162 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03373162?
The interventions under investigation include: onabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT03373162?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03373162 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03373162's enrollment target sits among peer trials
10 1035th of 1090 higher than 35 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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