Transorbital Alternating Current Stimulation in a Double-Masked Randomized Clinical Trial: Visual Functional Effect and Quality of Life

• DOI: 10.1016/j.xops.2024.100614
• Publication Date: 2024-09-04T18:34:47Z
• Authors: Maria de los Ange...; Ashley Sohn; Heather Livengood; Ting-Fang Lee; Batsheva Rubin; Jiyuan Hu; Bernhard A. Sabel; Rachel Matayev; Joseph Panarelli; Gadi Wollstein; Joel S. Schuman
• Keywords: Ophthalmology; glaucoma; VSI: Neuroprotection; 150; 610; clinical trial; Therapeutics; Health Services Administration; neurostimulation

PURPOSE: To determine the efficacy and safety of repetitive transorbital alternating current stimulation (rtACS) treatment by assessing vision-related quality of life and visual function outcome in subjects treated with rtACS versus sham-control. STUDY DESIGN: Double masked, randomized, sham-controlled clinical trial (NCT03188042). SUBJECTS: Sixteen subjects with moderate-to-advanced glaucoma (visual field [VF] mean deviation [MD] ≤−6.00 decibels) randomized into sham (9 subjects) or rtACS intervention (7 subjects) groups. METHODS: Subjects underwent 10 rtACS sessions over 2 weeks. All subjects had comprehensive ocular examination at baseline, 1-week, and 4-weeks posttreatment. MAIN OUTCOME MEASURES: Visual acuity (VA), contrast sensitivity (CS), VF MD, number of threshold sensitivity points that changed or were unchanged, and vision-related quality of life (VR-QoL) questionnaire scores. RESULTS: The rtACS group showed a significantly greater improvement from baseline to 4 weeks posttreatment compared with sham in VR-QoL domains including near activities (P < 0.01), dependency (P = 0.03), social functioning (P = 0.03), mental health (P < 0.01) and in the overall composite score (P = 0.04). No significant changes were detected with VA, CS, and VF analyses for either group. No serious adverse events were noted in either study group. CONCLUSIONS: Repetitive transorbital alternating current stimulation therapy showed a significant beneficial effect on several domains of VR-QoL. Further studies will determine its utility in glaucoma. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.