Functional Effects of Botox on the Brain Using MRS and fMRI

NCT ID: NCT03373162

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2018-03-16

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

MRI Scans Pre and Post-Botox Injection

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

Group Type: EXPERIMENTAL

onabotulinumtoxinA

Intervention Type: DRUG

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 .

Interventions

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 .

Intervention Type: DRUG

Other Intervention Names

Botox

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Stark, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

References

Stark S, Stark C, Wong B, Brin MF. Modulation of amygdala activity for emotional faces due to botulinum toxin type A injections that prevent frowning. Sci Rep. 2023 Feb 27;13(1):3333. doi: 10.1038/s41598-023-29280-x.

Reference Type: DERIVED

PMID: 36849797 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-3377

Identifier Type: -

Identifier Source: org_study_id