Functional Effects of Botox on the Brain Using MRS and fMRI

University of California Irvine (UCI)

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: onabotulinumtoxinA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03373162

2017-3377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 30 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MRI Scans Pre and Post-Botox Injection

Experimental group

Description:

Participants will receive MRI scans pre and post-Botox injection, including magnetic resonance spectroscopy, structural, and functional MRI.

Treatment:

Drug: onabotulinumtoxinA