Could a simple nerve stimulator ease chronic eye pain?
NCT ID NCT05531643
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether a TENS device, placed on the forehead, is safe and practical for treating chronic eye pain in 39 veterans. Participants used the device at home for 6 months. The goal was to see if it reduces pain and to prepare for a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous electrical nerve stimulation (TENS) device
- What this could lead to
- If it works, this could point toward a safe, non-drug option for managing chronic eye pain.
- What could go wrong
- This is a small pilot study with only 39 participants, so results may not apply to everyone. It focuses on safety and feasibility, not proof of effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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39 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Nov 2024
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * male or female * all races and ethnicities * at least 18 years of age * persistent eye pain for at least 6 months * average eye pain intensity of 4 or more on a 0-10 numerical rating scale * on a stable medication regimen for at least the past 3 months * naïve to TENS use for orofacial conditions * eye pain having neuropathic-like characteristics Exclusion Criteria: * presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.) * contraindication to TENS (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy) * patients with confirmed signs of tear dysfunction * current participation in another study with an investigational drug or device within one month prior to screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.