Electrostimulation Study for Ocular Graft vs. Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrodes with Currents, Electrodes without Currents.
- Who it may be relevant to
- Registry conditions: Chronic Ocular Graft-versus-host Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
Overview
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Detailed description
The trial is to test whether transcutaneous electrical stimulation (TES) may be an effective new type of non-invasive treatment for patients who are diagnosed with chronic ocular Graft-vs-Host Disease. Such a treatment can potentially decrease the need for the patients to apply eye drops frequently, repair the damage caused by chronic ocular Graft-vs-Host Disease, and improve the comfort of the eyes naturally.
Interventions
- Device Electrodes with Currents
Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins - Device Electrodes without Currents
Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
Primary outcome measures
- Efficacy of Electrostimulation (ES) Treatment. [Time frame: 8 Weeks]
Eligibility criteria
Inclusion criteria
- Diagnosis of chronic ocular graft vs. host disease (oGVHD) (ICCGVHD criteria probable or definite)
- OSDI score of 22 or higher
- NEI corneal staining score (or modified NEI score) of 2 or higher.
Exclusion criteria
- Patients with any open wound on the eyelid.
- Patient with any active cornea ulcer, dacryocystitis, hordeolum, filamentary keratitis, uveitis, retinal detachment, uncontrolled glaucoma or other active pathology per PI's discretion.
- Patient with a pacemaker or ICD.
- Patient currently pregnant or with a potential to be pregnant during the study.
- Patient undergoing any ocular surgical procedure (including intravitreal injections) within the past 3 months.
- Patient undergoing any systemic surgical procedures within 2 months.
- Patient undergoing any non-surgical eyelid procedure such as punctal plugs or punctal cautery within 1 month of study initiation.
- Patients on cytotoxic agents, drugs that inhibit peripheral nerve regeneration (i.e. Gabapentin, Nicotine), radiation therapy, or any other therapy per PI's discretion.
- Patients undergoing immunosuppression regimen change within 1 month of study initiation and/or during the study period.
- Patient who wears contact lens of any kind
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts Eye and Ear - Longwood Campus — Boston
Identifiers
NCT: NCT07166848 · 2025P002105