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NCT Number: NCT07166848

Electrostimulation Study for Ocular Graft vs. Host Disease

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts Eye and Ear - Longwood Campus

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Michael Cheung, MSc, CCRP

CONTACT

[email protected]

617-573-6060

Zhonghui Luo, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrodes with Currents

Device

Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins

Other names: Treatment

Electrodes without Currents

Device

Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins

Other names: Sham

Primary outcomes

  1. Efficacy of Electrostimulation (ES) Treatment.

    Time frame: 8 Weeks

    To evaluate whether the use of electrostimulation (ES) over a course of 10 treatments (in 8 weeks) will ameliorate symptoms and signs of chronic ocular Graft-vs-Host Disease (oGVHD) and the effect on sub-basal corneal nerve regeneration.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Cheung, MSc, CCRP

CONTACT

[email protected]

6175736060

Sponsors and collaborators

Lead sponsor

Zhonghui K. Luo, MD, PhD

Other

Registry information

Official study title

Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 10, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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