A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: rtACS Stimulation Group
|
Device: rtACS Stimulation
Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
|
| Sham Comparator: Sham Intervention Group Sham stimulation looks like rtACS, but is not active rtACS. |
Device: Sham Intervention
A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
|
Outcome Measures
Primary Outcome Measures
- Change in Optical coherence tomography (OCT) [baseline through 4 weeks]
Assess neuronal structure and function
- Change in OCT angiography [baseline through 4 weeks]
Assess neuronal structure and function
- Change in Magnetic resonance imaging (MRI) [baseline through 4 weeks]
Assess neuronal structure and function
- Change in Visual acuity [baseline through 4 weeks]
Assess areas of visual function
- Change in Contrast sensitivity [baseline through 4 weeks]
Assess areas of visual function
- Change in Score on Assessment of Life Habits (LIFE-H), short form 3.1 [baseline through 4 weeks]
Assess the feasibility of procedures for assessment of vision-related and health-related Quality of Life
- Change in score on National Eye Institute Visual Functioning Questionnaire (VFQ-39) [baseline through 4 weeks]
Assess the feasibility of procedures for assessment of vision-related and health-related QoL
- Change in score on 36-Item Short Form Survey (SF-36) [baseline through 4 weeks]
Assess the feasibility of procedures for assessment of vision-related and health-related QoL
Eligibility Criteria
Criteria
Inclusion Criteria:
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Live in a community, residential setting (i.e., non-institutionalized, not homeless)
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Diagnosis of glaucoma (not type-specific, excluding traumatic glaucoma): Moderate defect or worse in both eyes but not total blindness
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Visual field defects present for at least 6 months
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Best-corrected visual acuity of 20/200 (1.0 logMAR) or better in at least one eye
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Commitment to comply with study procedures (2 week period of intervention sessions) with baseline, post-intervention, and follow-up visits
Exclusion Criteria:
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Other optic comorbidity than glaucoma
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End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
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Other diseases of the retina or cataracts responsible for worse than 20/70 best-corrected visual acuity
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Photosensitivity to flickering lights
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Intraocular Pressure (IOP) > 27 mmHg at baseline
- Medically diagnosed memory disorder or Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27
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Electric or electronic implants (e.g., cardiac pacemaker)
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Metallic artifacts/implants in head and/or torso
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Diagnosed epilepsy
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Epileptic seizure within the past 3 years of enrollment date
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Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
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Metastatic disease
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Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would preclude reliable testing and participation
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Unstable medical conditions (e.g., diabetes, diabetes causing diabetic retinopathy)
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Claustrophobia (to limit functional neuroimaging)
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Received rtACS in the past
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Joel Schuman, MD, FACS, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-02005