Functional Effects of Botox on the Brain Using MRS and fMRI

Completed · Phase 4

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03373162

Run by

University of California, Irvine

People needed

10

Starts

2017-09-30

Expected to finish

2018-03-16

Last updated by the study team

2020-06-01

Who can join

Age: 30 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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