Clinical trial NCT03373162: Functional Effects of Botox on the Brain Using MRS and fMRI
Official title: Measuring the Functional Effects of Botox on the Brain Using MR Spectroscopy and fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2017-12-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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

Primary outcomes:
measure: Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox
timeFrame: 15-33 days between pre and post-Botox scans
measure: Change From Baseline in Functional MRI Mean Blood Oxygen Level Dependent (BOLD) Response in the Amygdala
timeFrame: 15-33 days between pre and post-Botox scans
Secondary outcomes:
measure: Number of Participants With Structural Brain Volume Change Following Botox Injections
timeFrame: 15-33 days between pre and post-Botox scans
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Craig Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References: