Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies

Korábbi kezelés

• Brain tumor or intracranial magnetic metallic implants.
• Participation in another clinical trial within the past 3 months involving medication or training that could affect the eyes.
• Previous ocular electrical stimulation treatment or visual training study within the past 12 months.

Más betegség

• History of ocular herpes.
• Retinal disease sufficient to affect vision.
• Uveitis or other intraocular inflammatory disease.
• Rheumatologic or autoimmune disease.
• History of epilepsy.
• History of claustrophobia.
• Physical or mental conditions that may increase the risk of participation or interfere with study assessments (e.g., dementia).
• Uncontrolled hypertension or diabetes.
• History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascular malformation, or intracranial surgery.

Egyéb

• Pathological nystagmus.
• Corneal opacity affecting vision.
• Cataract affecting vision.
• Implanted electronic devices such as a pacemaker.
• Periocular skin lesions.
• Anxiety with Geriatric Anxiety Scale score > 12.
• Pregnant or breastfeeding.

• Participant must be at least 18.
• Clinical diagnosis of glaucoma, with Humphrey Visual Field 24-2 mean deviation (MD) between -22 dB and -5 dB, and Visual Field Index (VFI) between 10% and 90%. The visual field test at screening must meet the following reliability indices:
  • Fixation losses (FL) ≤ 33%
  • False-negative rate (FNR) ≤ 20%
  • False-positive rate (FPR) ≤ 20% At initial screening, the difference in MD between two consecutive visual field tests must be less than 2 dB.
• Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulation treatment.
• If a participant has two eyes meeting study criteria, one eye will be randomly selected by computer for study participation.
• In the opinion of the investigator the participant's eye pressure must be clinically stable.
• Participant must has the ability to comply with the requirements of the study and complete the schedule of events.
• Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
• Optical coherence tomography (OCT) imaging shows measurable changes in either peripapillary retinal nerve fiber layer (RNFL) thickness or macular ganglion cell-inner plexiform layer thickness.