Botulinum Toxin for Light Sensitivity from Traumatic Brain Injury
Recruiting in Palo Alto (17 mi)
Overseen byAnat Galor, MD/MSPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Miami
Disqualifiers: Ocular diseases, Pregnant, Metal implants, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
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.
What data supports the effectiveness of the drug Botulinum Toxin Type A for light sensitivity from traumatic brain injury?
Is botulinum toxin type A generally safe for humans?
How is the drug Botulinum Toxin Type A unique for treating light sensitivity from traumatic brain injury?
Botulinum Toxin Type A (Botox) is unique because it works by blocking nerve signals to muscles, which can help reduce pain and muscle hyperactivity. Unlike standard treatments, it is injected directly into the affected area and has been used successfully for various pain conditions, including migraines and neuropathic pain, suggesting potential benefits for light sensitivity after brain injury.25101112
Eligibility Criteria
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 am 18 years or older and can give my consent.
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
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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
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Trial Timeline
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
Treatment Details
Interventions
- Botulinum Toxin Type A (Neurotoxin)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BoNT-A GroupExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
United States Department of DefenseCollaborator
References
Patient Registry of Spasticity Care World: Data Analysis Based on Physician Experience. [2018]The aim of the study was to report physician experience-based "real-world" treatment patterns with botulinum toxin type A in patients with stroke and traumatic brain injury.
Botulinum Toxin Type A for the Treatment of Post-traumatic Headache: A Randomized, Placebo-Controlled, Cross-over Study. [2021]Botulinum toxin type A (BoNT/A) is an approved treatment for chronic migraine and has been shown to be effective in reducing number, days, and severity of headache in other headache disorders. Whether botulinum toxin is a safe and effective treatment specifically for post-traumatic headache (PTH), however, is unknown. This study sought to determine whether treatment with BoNT/A improved symptoms of PTH in military veterans.
Botulinum toxin type A in the treatment of children and adolescents with an acquired brain injury. [2019]To describe clinical experience using botulinum toxin type A (BTX-A) in children with acquired brain injury.
Visual system side effects caused by parasympathetic dysfunction after botulinum toxin type B injections. [2015]Botulinum toxin type B (BTX-B) has been approved by the Food and Drug Administration for the treatment of cervical dystonia. However, as with botulinum toxin type A (BTX-A) it has off-label uses, such as for hyperhidrosis, focal dystonias, spasticity, and facial wrinkles. BTX-B has also been shown to be a safe and effective alternative for patients who are resistant to BTX-A. The most commonly reported side effects include dry mouth and dysphagia. To date, there have been few reports of visual disturbances associated with BTX-B use. In this study, we report on three individual patients who received BTX-B and who subsequently developed parasympathetic dysfunction of the visual system after injections of BTX-B at remote sites.
Application of botulinum toxin to clinical therapy: advances and cautions. [2012]The therapeutic use of botulinum toxin Type A has followed a novel and unanticipated pathway of applications, from its initial application by Scott to paralyze the extraocular muscles of the eyes to correct strabismus. In the late 1970s, Scott formed a company, called Oculinum Inc, to make botulinum toxin Type A available for this ophthalmic application. From this modest and limited beginning, it has found use for treatment of a plethora of cosmetic, neuromuscular, and skeletal disabilities, including cervical dystonia, blepharospasm, and temporary improvement in the appearance of moderate to severe glabellar lines. Botulinum toxin Type A is now being used as therapy in voiding disorders, migraine and tension-type headache, writer's cramp, and laryngeal muscle hyperactivity syndromes. It has reduced the spasm and pain associated with perianal fissures. It has found application in the reduction of glandular function in severe primary axillary hyperhidrosis and sialorrhea. Additional applications are being studied in the area of pain management based on its apparent ability to inhibit neuropeptide release from nociceptors.
Delayed Antitoxin Treatment of Two Adult Patients with Botulism after Cosmetic Injection of Botulinum Type A Toxin. [2018]Injection of botulinum toxin type A for cosmetic purposes is common. It is believed to be safe, but adverse reactions have been reported, including dysphagia, generalized paralysis, respiratory depression, and death caused by focal injection of the toxin. Early administration of antitoxin in patients with adverse reactions is the mainstay of management, but the time window for its clinical efficacy is not well defined.
Safety of botulinum toxin type A: a systematic review and meta-analysis. [2018]To define quantitatively the safety and tolerability profile of botulinum toxin type A (BTX-A) across all common therapeutic indications. The review was limited to the evaluation of the safety profile of one preparation of BTX-A (BOTOX) because distinct formulations of BTX-A are associated with different clinical profiles, requiring separate consideration for an analysis of safety.
Iatrogenic botulism after botulinum toxin type A injections. [2010]Therapeutic use of botulinum toxin type A (BT/A) is well known, effective, and safe. Iatrogenic botulism that presents with generalized weakness, dysphagia, and respiratory distress is a rare but significant complication in BT/A treatment. In this study, we report 4 patients who developed iatrogenic botulism after receiving therapeutic doses of BT/A for spasticity and blepharospasm. One patient was placed in intensive care unit, but consequently, every patient recovered fully. The cause of BT/A as an adverse effect is most likely hematological spread of the toxin.
Clinical results of botulinum toxin type a treatment of migraine headache. [2016]Clinical trials, retrospective studies, and case studies indicate that botulinum toxin type A is safe and effective for prophylactic and acute treatment of migraine headache. Further studies are needed to scientifically determine the optimum dosage and administration sites, and which patients are most likely to benefit from this treatment. (Aesthetic Surg J 2002;22:91-93.).
Botulinum toxin A and neuropathic pain: An update. [2023]Botulinum toxin type A is a widely used neurotoxin for the treatment of muscle hyperactivity such as dystonia and spasticity. Several clinical trials have also reported an efficacy of subcutaneous or intradermal administrations of botulinum toxin A on various neuropathic pain conditions including idiopathic trigeminal neuralgia and found that specific sensory phenotypes were predictors of the response. This narrative review summarizes the potential mechanisms of action, efficacy and safety of botulinum toxin A in neuropathic pain as well as its place in the therapeutic algorithm of neuropathic pain.
Botulinum toxin A relieved neuropathic pain in a case of post-herpetic neuralgia. [2018]Botulinum toxin type A (BTX-A) has been widely used in many clinical disorders including migraine, cervical dystonia, etc. The use of BTX-A in neuropathic pain, however, is uncommon, and the application of the anti-nociceptive effect of botulinum toxin is emerging. Here we report a case of an 80-year-old man who suffered from severe pain of post-herpetic neuralgia which was refractory to the usual therapies. However, this neuropathic pain was dramatically relieved by multiple BTX-A injection and the pain relief lasted 52 days.
Botulinum toxin injection technique for treatment of headaches. [2016]Botulinum toxin therapy may be considered for chronic daily headache when standard pharmacology is ineffective or results in adverse effects. Clinical observations and research suggest that botulinum toxin serotype A (BTX-A) may hold promise for pain treatment and headache prophylaxis by acting at the neuromuscular junction and through several antinociceptive mechanisms. This article introduces basic concepts that define headaches in the migraine continuum and provides an overview of BTX-A treatment. (Aesthetic Surg J 2002;22:65-68.).