Effect of Trigeminal Nerve Stimulation on Corneal Nerves and Chronic Ocular Pain
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| ClinicalTrials.gov Identifier: NCT04648085 |
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Recruitment Status :
Completed
First Posted : December 1, 2020
Last Update Posted : January 18, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Neuropathic Pain Eye Pain | Device: Trigeminal Nerve Stimulation | Not Applicable |
Dry eye is a multifactorial disease that produces a variety of clinical manifestations including, dryness, pain, blurred vision, and sensitivity to light or wind. Differences have been noted between the symptoms reported and the signs presented on physical examination, which suggests the involvement of somatosensory impairment. Ocular neuropathic pain is characterized by burning pain, hyperalgesia, photophobia, and sensitivity to wind. There are common physiopathological pathways, suggesting that corneal nerve sensitization contributes to the development of dry eye symptoms. Furthermore, in vivo confocal microscopy has reported a decrease in the density of the subbasal plexus in patients with a neuropathic component and dry eye, suggesting that they are not mutually exclusive conditions. Various topical treatments, as well as systemic medications are known to manage eye pain and dry eye. However, in some cases, individuals have been refractory to them, enhancing the importance of research in adjuvant therapies such as TNS.
This research protocol evaluates the effect of transcutaneous stimulation on corneal subbasal plexus density and chronic eye pain in patients with dry eye. A complete dry eye examination will be performed, including completion of Ocular Surface Disease Index (OSDI) and Dry Eye Questionnaire-5 (DEQ-5). Subbasal nerves density will be measured by confocal microscopy before and after receiving treatment with TNS. In addition, monthly monitoring of the intensity of ocular pain (with a numerical scale of 0-10) will be maintained. The intensity and severity of the clinical variables will be compared before and after receiving the treatment with a paired t-test considering a value of p<0.05 as statistically significant.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Prospective, open, single-arm pilot study without randomization. |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Effect of Trigeminal Nerve Stimulation on Subbasal Corneal Nerve Plexus Density and Chronic Ocular Pain in Patients With Dry Eye |
| Actual Study Start Date : | February 3, 2021 |
| Actual Primary Completion Date : | December 10, 2021 |
| Actual Study Completion Date : | December 10, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pre and Post Treatment with Trigeminal Nerve Stimulation (TNS)
Individuals will receive treatment with trigeminal nerve stimulation for 20 minutes at a frequency of 100 Hertz (Hz). Ocular pain intensity will be recorded prior and after the use of therapy.
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Device: Trigeminal Nerve Stimulation
Applied to to the forehead using a self-adhesive electrode positioned bilaterally over the upper branches of the trigeminal nerve.The device generates electrical impulses allowing to stimulate the trigeminal nerve. |
- Identify the effect of trigeminal nerve stimulation on chronic eye pain in patients with dry eye. [ Time Frame: From three-six months ]
Eye pain will be evaluated prior to the use of trigeminal nerve stimulation using a numeric pain scale ranging from 0-10, "0" indicating no pain and "10" indicating the most severe pain imaginable.
Pain will be evaluated posterior to therapy with trigeminal nerve stimulation with the same scale during monthly follow up.
- Identify the effect of trigeminal nerve stimulation on subbasal corneal nerve plexus density in patients with dry eye. [ Time Frame: 2 months- 6 months ]
Initial subbasal corneal nerve plexus density will be measured prior to therapy with with in vivo confocal microscopy.
Density measurements will be repeated every two months with in vivo confocal microscopy posterior to trigeminal nerve stimulation use.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Individuals with dry eye, Ocular pain for more than 3 months, Contact lens users, Individuals using topical treatment and/or systemic medication for dry eye syndrome, Individuals with history of photo-ablative ocular surgery (Laser-assisted in situ keratomileusis (LASIK) , Photorefractive keratectomy (PRK), Small incision lenticule extraction(SMILE), Individuals with history of autoimmune disease (Lupus, Rheumatoid Arthritis, Sjögrens),
Exclusion Criteria:
- Individuals with pacemakers or implantable defibrillators, Individuals with diagnosis of epilepsy, History of facial trauma one month prior to recruitment, Acute facial pain with unknown etiology, History of ocular surgery one month prior to recruitment, Trigeminal neuralgia, Active Herpes Zoster Ophthalmicus,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648085
| Mexico | |
| Instituto de Oftalmología Conde de Valenciana | |
| Mexico City, Cdmx, Mexico, 06800 | |
| Principal Investigator: | Simran Mangwani Mordani, MD | Instituto de Oftalmología Conde de Valenciana |
| Responsible Party: | Instituto de Oftalmología Fundación Conde de Valenciana |
| ClinicalTrials.gov Identifier: | NCT04648085 |
| Other Study ID Numbers: |
CI-006-2020 |
| First Posted: | December 1, 2020 Key Record Dates |
| Last Update Posted: | January 18, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Transcutaneous Electric Stimulation In vivo Confocal Microscopy Subbasal Corneal Nerve Plexus Dry Eye Neuropathic Pain |
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Neuralgia Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Pain Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases |
Keratitis Corneal Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Eye Manifestations |