Skip to main content
OpenTrials
Completed

NCT Number: NCT03373162

Functional Effects of Botox on the Brain Using MRS and fMRI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnabotulinumtoxinA

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 .

Other names: Botox

Primary outcomes

  1. Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox

    Time frame: 15-33 days between pre and post-Botox scans

    Determine whether there are metabolic differences in the brain stem in healthy individuals as a result of BOTOX using MRS. Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Metabolite FIDs were averaged within each task and processed using TARQUIN (v.4.3.6) software for spectral fitting. The acquired MRS spectra was corrected for tissue type and T2 relaxation differences. Using TARQUIN we obtained values for Glutamate + Glutamine (Glx), normalized by Creatine.

  2. Change From Baseline in Functional MRI Mean Blood Oxygen Level Dependent (BOLD) Response in the Amygdala

    Time frame: 15-33 days between pre and post-Botox scans

    Understand the effect of BOTOX on functional activity (measured using fMRI) in the brain. Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Participants viewed Happy and Angry faces and rated each one as pleasant or unpleasant. We then masked activity in the amygdala to investigate the difference in BOLD response for collapsed across emotion following Botox injections.

Secondary outcomes

  1. Number of Participants With Structural Brain Volume Change Following Botox Injections

    Time frame: 15-33 days between pre and post-Botox scans

    Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Structural scans for each participant were segmented using Freesurfer's automatic software for volumetric measures and then normalized by dividing by total intracranial volume for each participant. We then conducted t-tests for pre- vs. post- BOTOX injections to investigate any structural changes.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.