Traumatic Brain InjuryPhase 2NCT06293300
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
A Phase 2 study testing BoNT A in people with Traumatic Brain Injury, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- BoNT A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
- ≥18 years of age who are able to consent.
- Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (>1 year).
- Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition.
- Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
- English as primary language (by self-report).
Who cannot join
- Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
- Patients who are participating in another study with an investigational drug within one month prior to screening.
- Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or >12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.
- Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Mariela Aguilar, PhD, 3053266069, maguilar1@miami.edu
Anat Galor, MD/MSPH
About this study
Official title: Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
- Conditions
- Traumatic Brain Injury
- Being tested
- BoNT A
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoNT ADrug
Participants with TBI-associated photophobia will come one time in person to the clinic and receive 35 Units of BoNT-A injected in 7 forehead sites (0.1 cc in each location).
| Study group | Role | What they receive |
|---|---|---|
| BoNT-A Group | Experimental | Participants will receive BoNT-A intervention for up to 6 months. Receives: Drug: BoNT A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in photophobia measured by Numerical Rating Scale
The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Secondary outcomes (9)
Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)
Total score ranging from 8 to 40, with a higher score indicating more visual photosensitivity symptom severity.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).
Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)
Total score ranging from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
Total score ranging from 0 to 21, with higher scores indicating greater migraine severity.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
Total score ranging from 36 to 78, with higher scores indicating greater impact of headaches have on a person's ability to function on the job, at school, at home and in social situations.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
Total score ranging from 0 to 22, with higher scores indicating more dry eye symptoms.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)
Total score ranging from 0 to 100, will be administered to assess dry eye symptoms, with higher scores indicating more dry eye symptoms and impact on daily activities.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)
QST methodology will be used to measure the severity of painful sensations that remain present 15 seconds after presentation of 10 one-second presentations (each separated by one second) of a noxious stimulus to the skin of the forehead. Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable") will be recorded for these aftersensations.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)
QST methodology will be used to measure the increase in pain intensity ratings that occur when repeated noxious stimuli are presented in rapid succession (i.e., temporal summation; TS). Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable"). TS at each study time point will be determined by subtracting the rating of pain intensity at its peak during the rapid train of one-second noxious heat stimuli from the rating of pain intensity after a single one-second heat stimulus of the same temperature.
Measured: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Anat Galor, University of Miami
- Investigators
- Anat Galor, MD/MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293300
- Sponsor's protocol ID
- 20231056
- Other IDs
- HT94252310608
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
- ClinicalTrials.gov ID
- NCT06293300
- Acronym / sponsor ID
- 20231056
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BoNT-A Group | Experimental | Drug: BoNT AParticipants will receive BoNT-A intervention for up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
- ≥18 years of age who are able to consent.
- Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (>1 year).
- Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition.
- Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
Key exclusion criteria (4 listed)
- Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
- Patients who are participating in another study with an investigational drug within one month prior to screening.
- Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or >12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.
- Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoNT AParticipants with TBI-associated photophobia will come one time in person to the clinic and receive 35 Units of BoNT-A injected in 7 forehead sites (0.1 cc in each location). | Drug | BoNT-A Group |
Primary outcome
Change in photophobia measured by Numerical Rating Scale
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.
9 secondary outcomes
Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anat Galor, MD/MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BoNT A in people with Traumatic Brain Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anat Galor, MD/MSPH ((305) 3266000, agalor@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in photophobia measured by Numerical Rating Scale (time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.