Phase 4
N=10
Functional Effects of Botox on the Brain Using MRS and fMRI
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03373162 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox — .12 Brainstem GLX/Cr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- onabotulinumtoxinA (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox |
.12 | — |
| PRIMARY Change From Baseline in Functional MRI Mean Blood Oxygen Level Dependent (BOLD) Response in the Amygdala |
-1.7 | — |
| SECONDARY Number of Participants With Structural Brain Volume Change Following Botox Injections |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Females
- Ages 30-40 years of age
- Right-handed
- Normal or corrected-to-normal vision
- No history of psychiatric, neurological, or medical co-morbidities that might interfere with normal brain functioning
- Fluent in English
- Moderate to severe glabellar lines
Exclusion Criteria
- Pregnancy
- Ferrous metal, a pacemaker, or other battery-operated device implanted in the body
- Claustrophobia
- Known hypersensitivity to Botulinum Toxin
- Infection on the forehead or between the eyes
- Urinary tract infection
Data sourced from ClinicalTrials.gov (NCT03373162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.