Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Официальное название

An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies

Обзор

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).

Вмешательства

• Устройство SAVIR Alpha Synch mobile (SASm)
  The 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.

Первичные конечные точки

• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [Срок оценки: baseline, 1 week post-intervention]
• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [Срок оценки: baseline, 3 months post-intervention]
• Change in peripapillary retinal nerve fiber layer (RNFL) thickness (µm) [Срок оценки: baseline, 6 months post-intervention]
• Change in macular ganglion cell-inner plexiform layer thickness (µm) [Срок оценки: baseline, 1 week post-intervention]
• Change in macular ganglion cell-inner plexiform layer thickness (µm) [Срок оценки: baseline, 3 months post-intervention]
• Change in macular ganglion cell-inner plexiform layer thickness (µm) [Срок оценки: baseline, 6 months post-intervention]
• Change in optic nerve (ON) head cup-to-disc ratio (%) [Срок оценки: baseline, 1 week post-intervention]
• Change in optic nerve (ON) head cup-to-disc ratio (%) [Срок оценки: baseline, 3 months post-intervention]
• Change in optic nerve (ON) head cup-to-disc ratio (%) [Срок оценки: baseline, 6 months post-intervention]
• Change in Humphrey Visual Field Analyzer (HFA) score [Срок оценки: baseline, 1 week post-intervention]

Вторичные конечные точки (5)

• Number of scheduled clinical appointments reviewed [Срок оценки: Month 6]
• Number of patients considered potentially eligible as determined during review of the clinical appointment schedule [Срок оценки: Month 6]
• Number of patients who are potentially eligible but express no interest in participating in the study [Срок оценки: Month 6]
• Number of patients who are determined ineligible following screening procedures [Срок оценки: Month 6]
• Number of participants' who adhered to the study protocol regimen [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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%
• Visual Field Index (VFI) 10-90%
• Clear optical apparatus
• Best-corrected VA of 20/400 or better in at least one eye
• Commitment to comply with study procedures: 8-week period of intervention sessions (30 sessions every other day), baseline visit, post-intervention visit, and 2 follow-up visits (2 days per visit).

• Scheduling
• Testing
• A subject deemed incapable of performing the study intervention independently due to visual impairment or any other condition that may prevent them from performing the intervention accurately require a family member or caregiver to assist in performing the intervention.

Критерии исключения

• 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
• Acute conjunctivitis
• Photosensitivity to flickering lights
• Non-ocular/ocular surgery within the previous 2 months to enrollment date
• Electric or electronic implants (e.g., cardiac pacemaker)
• Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed)
• Diagnosed epilepsy on medical treatment
• Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
• Metastatic disease
• Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks
• Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits
• Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year
• Uncontrolled systemic hypertension (historical BP > 160/100 mmHg)
• Pregnant or breast-feeding women or women that are planning to become pregnant, as this device has not been tested on pregnant women and there is no data on using rtACS for this particular group
• Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or other skin defect which compromise the integrity of the skin at or near stimulation locations
• IOP that the principal investigator determines that is not clinically stable
• Complete blindness of both eyes
• Non-resected brain tumors
• Unstable diabetic retinopathy in the study eye
• Optic neuropathies secondary to brain tumors
• Subjects without the capacity to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06662448 · 24-01043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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