A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
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- STATUS
- Recruiting
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- End date
- Mar 24, 2024
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- participants needed
- 20
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- sponsor
- NYU Langone Health
Summary
This pilot study will test the preliminary efficacy and feasibility of an intervention protocol for one method of electric current stimulation, repetitive transorbital alternating current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS to ameliorate the progressive effects of vision loss both structurally and functionally in the eye, the visual pathway, and in regard to people's independence (i.e., functional ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1) determine an effect of rtACS on ophthalmic structure and function (from retina to visual brain), 2) assess the methodology of procedures for assessment of people's functional ability and QoL to determine an effect of rtACS, and 3) assess the feasibility and implementation of the pilot study protocol for a larger multi-site, randomized controlled trial.
Description
Participants will engage in baseline, intervention, post-intervention, and follow-up visits over the span of approximately 8 weeks. The expected outcomes for this project are that (1) rtACS activates viable but poorly or non-functional retinal ganglion cells to improve their structural and functional capabilities, (2) measures of retinal, optic nerve, and visual brain structures and function will correspond with improvement in visual function, and (3) changes in visual function following rtACS will be associated with improvements in participants' functional ability and QoL. rtACS has successfully been used in the rehabilitation of visual impairments in people with optic neuropathies; however, we do not know the clinical value of rtACS specifically for people with glaucoma, including the effect of rtACS on people's functional ability and QoL.
Details
| Condition | Glaucoma |
|---|---|
| Treatment | sham intervention, rtACS Stimulation |
| Clinical Study Identifier | NCT03188042 |
| Sponsor | NYU Langone Health |
| Last Modified on | 24 March 2022 |
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