Functional Effects of Botox on the Brain Using MRS and fMRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03373162
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: onabotulinumtoxinA Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Measuring the Functional Effects of Botox on the Brain Using MR Spectroscopy and fMRI
Actual Study Start Date : September 30, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Pre-Post
Participants will receive MRI scans pre and post-Botox injection
Drug: 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 .
Other Name: Botox

Primary Outcome Measures :
  1. MRS in brainstem [ Time Frame: 30-45 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

  2. functional MRI in amygdala and rest of brain [ Time Frame: 30-45 days between pre and post-Botox scans ]
    understand the effect of BOTOX on functional activity (measured using fMRI) in the brain and in the brainstem

Secondary Outcome Measures :
  1. Structural brain volume changes [ Time Frame: 30-45 days between pre and post-Botox scans ]
    compare region-of-interest volumes controlling for total intracranial volume (estICV) as a result of Botox

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03373162

United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Craig Stark, PhD University of California, Irvine

Responsible Party: University of California, Irvine Identifier: NCT03373162     History of Changes
Other Study ID Numbers: 2017-3377
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents