CClinicalTrials.gg
Sign In
Enrolling by invitationNCT07166848Updated Aug 21, 2026

Electrostimulation Study for Ocular Graft vs. Host Disease

An interventional study of Electrodes with Currents and Electrodes without Currents in Chronic Ocular Graft-versus-host Disease, sponsored by Zhonghui K. Luo, MD, PhD. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Zhonghui K. Luo, MD, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Ocular Graft-versus-host Disease

Keywords

  • GVHD
  • Electrostimulation
03

In context

Lead sponsor

This is the only study on the registry with Zhonghui K. Luo, MD, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Electrostimulation

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

    Device: Electrodes with Currents

  • Sham comparator
    Sham

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

    Device: Electrodes without Currents

Interventions

  • DeviceElectrodes with Currents

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

    Also known as: Treatment

  • DeviceElectrodes without Currents

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

    Also known as: Sham

06

What researchers measure

Primary outcomes

  1. Efficacy of Electrostimulation (ES) Treatment.

    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.

    Time frame: 8 Weeks

07

Study locations

1 site
  • Massachusetts Eye and Ear - Longwood Campus
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07166848
Lead sponsor
Zhonghui K. Luo, MD, PhD
Responsible party
Zhonghui K. Luo, MD, PhD (Principal Investigator, Massachusetts Eye and Ear Infirmary) — Sponsor-investigator
First posted
Sep 10, 2025
Start date
Nov 30, 2025
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2029 (estimated)
Last update
Aug 21, 2026

Study contacts

Zhonghui Luo, MD, PhD
principal investigator · Massachusetts Eye and Ear Infirmary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion