Electrostimulation Study for Ocular Graft vs. Host Disease

Zhonghui K. Luo, MD, PhD

Status: Enrolling

Conditions: Chronic Ocular Graft-versus-host Disease

Treatments: Device: Electrodes without Currents; Device: Electrodes with Currents

Study type: Interventional

Funder types: Other

Identifiers

NCT07166848

2025P002105

Details and patient eligibility

About

This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Electrostimulation

Experimental group

Description:

The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.

Treatment:

Device: Electrodes with Currents

Sham

Sham Comparator group

Description:

The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.

Treatment:

Device: Electrodes without Currents