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This trial is testing to see if electrostimulation treatment (ET) will be effective in treating those with ocular Graft vs. Host Disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrostimulation | Experimental | The experimental group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITH amplitude. |
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| Sham | Sham Comparator | The placebo group will entail the subject wearing the electrodes on the cheeks and forehead, for 30 minutes WITHOUT amplitude. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrodes with Currents | Device | Electrodes will be placed on the cheeks and forehead, and treated with an amplitude of 300 µA for 30 mins |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Cheung, MSc, CCRP | Contact | 6175736060 | mcheung0@meei.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zhonghui Luo, MD, PhD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear - Longwood Campus | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D004566 | Electrodes |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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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.
| Electrodes without Currents | Device | Electrodes will be placed on the cheeks and forehead, and treated with an no amplitude for 30 mins |
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