Trial Outcomes & Findings for Functional Effects of Botox on the Brain Using MRS and fMRI (NCT NCT03373162)
NCT ID: NCT03373162
Last Updated: 2020-06-01
Results Overview
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.
COMPLETED
PHASE4
10 participants
15-33 days between pre and post-Botox scans
2020-06-01
Participant Flow
Participant milestones
| Measure |
MRI Scans Pre and Post-Botox Injections
Participants will receive MRI scans pre and post-Botox injection
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 .
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Effects of Botox on the Brain Using MRS and fMRI
Baseline characteristics by cohort
| Measure |
Pre-Post
n=10 Participants
Participants will receive MRI scans pre and post-Botox injection
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 .
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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10 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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10 participants
n=5 Participants
|
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MRS measures of Glx normalized to Creatine
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1.9 Concentration Ratio
STANDARD_DEVIATION .49 • n=5 Participants
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BOLD fMRI activity in Left Amygdala: Happy faces vs baselines task
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1.4 Beta value
STANDARD_DEVIATION .06 • n=5 Participants
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BOLD fMRI activity in Left Amygdala: Angry faces vs baselines task
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.08 Beta values
STANDARD_DEVIATION .08 • n=5 Participants
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PRIMARY outcome
Timeframe: 15-33 days between pre and post-Botox scansDetermine 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.
Outcome measures
| Measure |
MRI Scans Pre and Post-Botox Injection
n=10 Participants
Participants will receive MRI scans pre and post-Botox injection
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 .
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|---|---|
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Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox
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.12 Brainstem GLX/Cr
Standard Error .44
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PRIMARY outcome
Timeframe: 15-33 days between pre and post-Botox scansUnderstand 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.
Outcome measures
| Measure |
MRI Scans Pre and Post-Botox Injection
n=10 Participants
Participants will receive MRI scans pre and post-Botox injection
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 .
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|---|---|
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Change From Baseline in Functional MRI Mean Blood Oxygen Level Dependent (BOLD) Response in the Amygdala
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-1.7 fMRI BOLD in Left Amygdala
Standard Error .45
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SECONDARY outcome
Timeframe: 15-33 days between pre and post-Botox scansParticipants 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.
Outcome measures
| Measure |
MRI Scans Pre and Post-Botox Injection
n=10 Participants
Participants will receive MRI scans pre and post-Botox injection
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 .
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|---|---|
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Number of Participants With Structural Brain Volume Change Following Botox Injections
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0 Participants
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Adverse Events
Pre-Post
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Craig Stark, Professor
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60