NCT03373162

Functional Effects of Botox on the Brain Using MRS and fMRI

Measuring the Functional Effects of Botox on the Brain Using MR Spectroscopy and fMRI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 30 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will receive one MRI scan session prior to a standardized, clinical dose of BOTOX injected into the forehead per FDA-approved procedures. Participants will then undergo a second MRI scan session 2-3 weeks later, after the BOTOX has taken maximal effect. Examining fMRI of the brainstem and the functional connectivity of the brainstem and connections to cortex, may provide additional insight into the effects of BOTOX on neurologic and psychiatric disorders.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	onabotulinumtoxinA	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 .

Timeline

• Start date: 2017-09-30
• Primary completion: 2018-03-16
• Completion: 2018-03-16
• First posted: 2017-12-14
• Last updated: 2020-06-01
• Results posted: 2019-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study