Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
ConditionOptic Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with optic neuropathy. The primary aims are to evaluate the effectiveness of home-based rtACS to ameliorate the progressive effects of vision loss functionally in the eye and the visual pathway, and in regard to people's independence (i.e., functional ability).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age equal to or over 18 years old
Must have a permanent residence
Diagnosis of optic neuropathy
VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN <33%
Disqualifiers
High intraocular pressure (over 27 mmHg)
End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
Advanced or unstable retinal diseases
Pathological nystagmus
Trial design
Design model
Single group
Treatments tested in this trial
SAVIR Alpha Synch mobile (SASm)
DeviceThe SAVIR Alpha Synch mobile is a device first used in office and then intended to be used for the home therapy of the visual system with non-invasive electrical stimulation.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Home-based Repetitive Transorbital Alternating Current Stimulation (rtACS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Outcome measure will be assessed using Optical coherence tomography (OCT).
Time frame
baseline, 1 week post-intervention2
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Outcome measure will be assessed using Optical coherence tomography (OCT).
Time frame
baseline, 3 months post-intervention3
Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm)
Outcome measure will be assessed using Optical coherence tomography (OCT).
Time frame
baseline, 6 months post-intervention4
Change in macular ganglion cell-inner plexiform layer thickness (µm)
Outcome measure will be assessed using Optical coherence tomography (OCT).
Time frame
baseline, 1 week post-interventionSecondary outcomes
1
Number of scheduled clinical appointments reviewed
Time frame
Month 62
Number of patients considered potentially eligible as determined during review of the clinical appointment schedule
Time frame
Month 63
Number of patients who are potentially eligible but express no interest in participating in the study
Time frame
Month 64
Number of patients who are determined ineligible following screening procedures
Time frame
Month 6Sponsors and contacts
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Source ClinicalTrials.gov