Pilot Trial of Non-invasive Electrostimulation in Chronic Ocular Graft-vs-Host Disease
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Massachusetts Eye and Ear - Longwood Campus
RECRUITING
Boston
Contact Information
Primary
Michael Cheung, MSc, CCRP
mcheung0@meei.harvard.edu
6175736060
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 15
Treatments
Experimental: Electrostimulation
The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.
Sham_comparator: Sham
The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.
Related Therapeutic Areas
Sponsors
Leads: Zhonghui K. Luo, MD, PhD