Electrostimulation Study for Ocular Graft vs. Host Disease
NCT ID: NCT07166848
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
15 participants
INTERVENTIONAL
2025-11-30
2029-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Electrostimulation
The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude.
Electrodes with Currents
Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins
Sham
The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude.
Electrodes without Currents
Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Electrodes with Currents
Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins
Electrodes without Currents
Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* OSDI score of 22 or higher
* NEI corneal staining score (or modified NEI score) of 2 or higher.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhonghui K. Luo, MD, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhonghui K. Luo, MD, PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhonghui Luo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear Infirmary
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts Eye and Ear - Longwood Campus
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025P002105
Identifier Type: -
Identifier Source: org_study_id