At a glance
ClinicalIndex Comparison Record- ✓Female sex
- ✓Age 30–40 years
- ✓Right-handed
- ✓Normal or corrected-to-normal vision
- ✕Pregnancy
- ✕Ferrous metal, pacemaker, or other battery-operated device implanted in the body
- ✕Claustrophobia
- ✕Known hypersensitivity to Botulinum Toxin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Measuring the Functional Effects of Botox on the Brain Using MR Spectroscopy and fMRI
In Brief
A Phase 4 clinical trial evaluating onabotulinumtoxinA for Healthy. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA .