Botulinum Toxin for Light Sensitivity from Traumatic Brain Injury

Overseen By Anat Galor, MD/MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Disqualifiers: Ocular diseases, Pregnant, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Botulinum Toxin Type A (commonly known as Botox) can help treat light sensitivity caused by a traumatic brain injury (TBI). Researchers seek to understand how this treatment affects visual function and the day-to-day impact of light sensitivity. Participants should have experienced TBI over a year ago and suffer from chronic light sensitivity that significantly affects daily life. They should also have been on stable medication for the last three months and have never used Botox for facial issues. If these criteria match your situation, this trial might be suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable medication regimen for the past 3 months, so you will not need to stop taking your current medications.

Is there any evidence suggesting that Botulinum Toxin Type A is likely to be safe for humans?

Research shows that Botulinum Toxin Type A is under study for its safety and effectiveness in treating symptoms like light sensitivity caused by Traumatic Brain Injury (TBI). Previous studies have used this toxin for various conditions, demonstrating promise in reducing pain and discomfort, particularly for those with ongoing pain and light sensitivity.

Participants in these studies generally handled the treatment well, with few reports of serious side effects. Most side effects, if any, were mild and temporary, such as slight pain at the injection site or mild muscle weakness. Research suggests that this treatment is usually safe, but more studies are needed to fully understand its safety for TBI-related light sensitivity.

This trial is in Phase 2, indicating that early safety tests have been mostly positive. However, further testing is necessary to confirm these early results. Always consult a healthcare provider for personalized advice and informed decision-making. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for light sensitivity resulting from traumatic brain injury involve medications like anti-seizure drugs or antidepressants, which often work by altering brain chemistry to manage symptoms. Unlike these options, Botulinum Toxin Type A (BoNT-A) offers a novel approach by targeting nerve communication pathways directly. Researchers are excited about BoNT-A because it acts on the neuromuscular junctions, potentially reducing light sensitivity by modulating nerve signals more precisely. This mechanism could offer relief without the systemic side effects associated with traditional medications, making it a promising option for patients seeking targeted therapy.

What evidence suggests that Botulinum Toxin Type A might be an effective treatment for light sensitivity from TBI?

Research has shown that botulinum toxin type A (BoNT-A) might help with sensitivity to light. Recipients of BoNT-A injections for migraines often report less discomfort from bright lights. This effect may occur because BoNT-A calms brain areas involved in pain and light sensitivity. Some studies also suggest that BoNT-A could alleviate symptoms after a traumatic brain injury. Overall, early research is promising for its use in treating light sensitivity related to brain injuries. Participants in this trial will receive BoNT-A intervention for up to 6 months to evaluate its effectiveness for light sensitivity following traumatic brain injury. ^{1 2 3 5 6}

Who Is on the Research Team?

Anat Galor, MD/MSPH

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a traumatic brain injury (TBI) at least a year ago and suffer from chronic light sensitivity. They must speak English, not have received BoNT-A treatment for orofacial conditions, and be on stable medication for the last three months. People with certain eye diseases, pregnant individuals, those in other drug studies recently, or with contraindications to fMRI scans cannot participate.

Inclusion Criteria

English must be the primary language by self-report

I have had severe sensitivity to light for over 6 months due to a past brain injury.

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

Exclusion Criteria

Patients who are participating in another study with an investigational drug within one month prior to screening

I do not have eye conditions like glaucoma or corneal scars that could affect sensitivity to light.

Pregnant individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BoNT-A intervention for up to 6 months

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum Toxin Type A

Trial Overview The study aims to understand and treat light sensitivity due to TBI using Botulinum Toxin Type A (BoNT-A). It will assess how this treatment affects visual function in people who've experienced TBI.

How Is the Trial Designed?

Group I: BoNT-A Group Experimental Treatment 1 Intervention

Participants will receive BoNT-A intervention for up to 6 months.

Botulinum Toxin Type A is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Botox for:

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus
• Cervical dystonia
• Chronic migraine
• Overactive bladder
• Detrusor overactivity associated with a neurologic condition

Approved in European Union as Botox for:

• Glabellar lines
• Facial wrinkles and folds
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus
• Cervical dystonia
• Chronic migraine
• Overactive bladder
• Detrusor overactivity associated with a neurologic condition
• Spasticity of the upper limb

Approved in Canada as Botox for:

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus
• Cervical dystonia
• Chronic migraine
• Overactive bladder
• Detrusor overactivity associated with a neurologic condition

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

An 80-year-old man with severe post-herpetic neuralgia experienced significant pain relief after receiving multiple injections of botulinum toxin type A (BTX-A), which is not commonly used for neuropathic pain.

The pain relief lasted for 52 days, suggesting that BTX-A may be an effective treatment option for patients with neuropathic pain that does not respond to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin A relieved neuropathic pain in a case of post-herpetic neuralgia. Liu, HT., Tsai, SK., Kao, MC., et al.[2018]

Botulinum toxin type B (BTX-B) is an FDA-approved treatment for cervical dystonia and serves as a safe and effective alternative for patients who do not respond to botulinum toxin type A (BTX-A).

While BTX-B is generally well-tolerated, this study highlights rare cases of visual disturbances linked to its use, indicating the need for awareness of potential side effects beyond the commonly reported dry mouth and dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual system side effects caused by parasympathetic dysfunction after botulinum toxin type B injections. Dubow, J., Kim, A., Leikin, J., et al.[2015]

Botulinum toxin type A (BT/A) is generally safe and effective for treating conditions like spasticity and blepharospasm, but there is a rare risk of iatrogenic botulism, which can cause serious symptoms such as weakness and respiratory distress.

In a study of 4 patients who developed iatrogenic botulism after BT/A treatment, all patients fully recovered, suggesting that while the complication is serious, the overall safety profile of BT/A remains strong.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic botulism after botulinum toxin type A injections. Coban, A., Matur, Z., Hanagasi, HA., et al.[2010]

In a pilot study involving 21 children with acquired brain injury, botulinum toxin type A (BTX-A) was found to be effective in improving comfort and function, particularly in patients with upper limb spasticity, who showed lasting benefits for at least 5 months post-treatment.

The study highlights the importance of clearly defined treatment goals, as all groups experienced initial improvements, indicating that BTX-A can be tailored to address specific impairments in children with brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in the treatment of children and adolescents with an acquired brain injury. van Rhijn, J., Molenaers, G., Ceulemans, B.[2019]

Botulinum toxin type A is effective in treating various neuropathic pain conditions, such as idiopathic trigeminal neuralgia, with specific sensory phenotypes helping to predict patient response.

The review highlights the safety and potential mechanisms of action of botulinum toxin A, positioning it as a valuable option in the treatment strategy for neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin A and neuropathic pain: An update. Spagna, A., Attal, N.[2023]

Botulinum toxin serotype A (BTX-A) is a potential treatment for chronic daily headaches, especially when standard medications are ineffective or cause side effects.

BTX-A may work by blocking pain signals at the neuromuscular junction and through various pain-relieving mechanisms, suggesting it could be an effective option for headache prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin injection technique for treatment of headaches. Wheeler, AH.[2016]

A meta-analysis of 36 randomized controlled trials involving 2309 subjects found that botulinum toxin type A (BOTOX) has a favorable safety profile, with no severe adverse events reported.

While mild to moderate adverse events occurred in about 25% of patients treated with BOTOX, focal weakness was the only side effect significantly more common than in the control group, indicating that BOTOX is generally well-tolerated across various therapeutic uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of botulinum toxin type A: a systematic review and meta-analysis. Naumann, M., Jankovic, J.[2018]

In a study involving 759 patients (627 with stroke and 132 with traumatic brain injury), more experienced physicians administered higher doses of onabotulinumtoxinA (BOTOX) and achieved better outcomes in reducing muscle stiffness, as measured by the Ashworth Scale, compared to less experienced physicians.

Patients treated by more experienced physicians reported higher satisfaction with their treatment outcomes, indicating that physician experience plays a significant role in the effectiveness of botulinum toxin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Registry of Spasticity Care World: Data Analysis Based on Physician Experience. Esquenazi, A., Lee, S., Mayer, N., et al.[2018]

In a study of 40 military veterans with post-traumatic headache (PTH), treatment with botulinum toxin type A (BoNT/A) resulted in a significant reduction in the number of headaches per week by 43.3% and headache days per week by 44.4% compared to placebo, indicating its efficacy for PTH.

BoNT/A also significantly decreased headache pain severity, demonstrating its potential as a safe and effective treatment option for veterans suffering from PTH, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Type A for the Treatment of Post-traumatic Headache: A Randomized, Placebo-Controlled, Cross-over Study. Zirovich, MD., Pangarkar, SS., Manh, C., et al.[2021]

Botulinum toxin Type A has evolved from its original use for treating eye muscle disorders to a wide range of applications, including cosmetic treatments and various medical conditions like migraines, cervical dystonia, and excessive sweating.

Its mechanism of action involves inhibiting neuropeptide release from nerve endings, which may contribute to its effectiveness in pain management and other therapeutic areas, highlighting its versatility as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of botulinum toxin to clinical therapy: advances and cautions. Levy, NS., Lowenthal, DT.[2012]

Botulinum toxin type A has been shown to be both safe and effective for treating migraine headaches, based on various clinical trials and studies.

Further research is necessary to establish the best dosage, administration sites, and to identify which patients will benefit the most from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of botulinum toxin type a treatment of migraine headache. Silberstein, SD.[2016]

Two cases of clinical botulism occurred in female patients after receiving botulinum toxin type A injections for cosmetic purposes, highlighting potential serious adverse reactions from these treatments.

Both patients showed clinical improvement after receiving botulinum antitoxin 7 and 9 days post-symptom onset, suggesting that antitoxin treatment may still be effective even when administered late.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Antitoxin Treatment of Two Adult Patients with Botulism after Cosmetic Injection of Botulinum Type A Toxin. Fan, KL., Wang, YL., Chu, G., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11510946/

Onabotulinumtoxin A for the Treatment of Post-Traumatic ... This review evaluates the use of onabotulinumtoxin A (ONA) and anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) in the treatment of PTH.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7350146/

Periorbital botulinum toxin A improves photophobia and ... Individuals receiving botulinum toxin A (BoNT-A) injections in the head and neck for migraine treatment have reported decreases in photophobia ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1202341/full

Botulinum toxin A decreases neural activity in pain-related ... Discussion: BoNT-A injections modulate light-evoked activation of pain-related brain systems and photophobia symptoms in some individuals with ...

4. academic.oup.com academic.oup.com/milmed/article/186/5-6/493/6006401

Botulinum Toxin Type A for the Treatment of Post-traumatic ... This study sought to determine whether treatment with BoNT/A improved symptoms of PTH in military veterans.

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-02159-0

OnabotulinumtoxinA inhibits dysregulation of descending pain ... Early or delayed administration of onabotulinumtoxinA was effective in inhibiting mTBI-induced dysregulation of DCN, indicating its potential in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10117778/

Clinical efficacy of botulinum toxin type A in patients with ... Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal ...