Trial · NCT06293300
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
NCT06293300, Phase 2, Recruiting, University of Miami
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A). Trials, record NCT06293300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06293300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
- NCT number
- NCT06293300
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- University of Miami
- Conditions
- Traumatic Brain Injury
- Interventions
- BoNT A
- First posted
- 2024-03-05
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in photophobia measured by Numerical Rating Scale | 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"). |
| Primary | Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) | 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. |
| Secondary | Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | Total score ranging from 8 to 40, with a higher score indicating more visual photosensitivity symptom severity. |
| Secondary | Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye). | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity. |
| Secondary | Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | Total score ranging from 0 to 100, with higher scores indicating better quality of life. |
| Secondary | Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | Total score ranging from 0 to 21, with higher scores indicating greater migraine severity. |
| Secondary | Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6 | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | 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. |
| Secondary | Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | Total score ranging from 0 to 22, with higher scores indicating more dry eye symptoms. |
| Secondary | Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | 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. |
| Secondary | Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST) | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06293300
GET https://conductscience.org/api/trials/v1/NCT06293300/registered