Electrostimulation Study for Ocular Graft vs. Host Disease

NCT07166848 | Recruiting

• 1 other identifier: 2025P002105
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Ocular Graft-versus-host Disease

Keywords

GVHD; Electrostimulation

Outcome Measures

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.

  8 Weeks

Study Arms (2)

Electrostimulation

EXPERIMENTAL

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

SHAM COMPARATOR

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

Electrodes with Currents DEVICE

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

Also known as: Treatment

Electrostimulation

Electrodes without Currents DEVICE

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

Also known as: Sham

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhonghui K. Luo, MD, PhD: lead

Study Sites (1)

Massachusetts Eye and Ear - Longwood Campus

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Interventions

Electrodes; Therapeutics

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Zhonghui Luo, MD, PhD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cheung, MSc, CCRP

CONTACT

6175736060; mcheung0@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The principal investigator and the participants will be masked to treatment. The study staff setting up the device will be the only staff who will know the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 10, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)