Repeated transcranial alternating current stimulation to improve vision in glaucoma

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

This trial will try repeated transcranial alternating current stimulation to see if it can reactivate damaged retinal ganglion cells and improve visual function in people with glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei, Hawaii)
• Trial ID: NCT07145073 on ClinicalTrials.gov

What this trial studies

This interventional study uses a DC-Stimulator MC to deliver repeated transcranial alternating current stimulation (rtACS) aimed at activating impaired retinal ganglion cells in adults with glaucoma. Participants must have reliable Humphrey Visual Field 24-2 results with mean deviation between -22 and -5 dB and a Visual Field Index between 10% and 90%, and a best-corrected visual acuity of at least 0.2 in the worse eye selected for stimulation. If both eyes meet criteria, one eye will be randomly selected for treatment, and investigators require clinically stable intraocular pressure and the ability to complete study visits. Outcomes will include structural and functional measures of the retina and visual field performance to determine whether repeated rtACS produces measurable improvement or stabilization.

Who should consider this trial

Good fit: Adults (≥18) with a clinical diagnosis of glaucoma, reliable Humphrey Visual Field 24-2 results with MD between -22 and -5 dB and VFI 10–90%, and best-corrected visual acuity ≥0.2 in the treated eye are ideal candidates.

Not a fit: Patients with very advanced or minimal disease outside the specified visual field ranges, unreliable visual field tests, unstable intraocular pressure, or who cannot attend in-person stimulation visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could restore some retinal ganglion cell activity and lead to improved or stabilized visual field and vision for people with glaucoma.

How similar studies have performed: Small, early studies of transcranial/transorbital electrical stimulation for optic neuropathies have reported modest and variable improvements in visual function, but evidence remains preliminary and not yet definitive.

Eligibility criteria

Inclusion Criteria:

1. Participant must be at least 18.
2. 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.
3. Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulation treatment.
4. If a participant has two eyes meeting study criteria, one eye will be randomly selected by computer for study participation.
5. In the opinion of the investigator the participant's eye pressure must be clinically stable.
6. Participant must has the ability to comply with the requirements of the study and complete the schedule of events.
7. 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.
8. 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.

Exclusion Criteria:

1. History of ocular herpes.
2. Pathological nystagmus.
3. Retinal disease sufficient to affect vision.
4. Corneal opacity affecting vision.
5. Cataract affecting vision.
6. Uveitis or other intraocular inflammatory disease.
7. Implanted electronic devices such as a pacemaker.
8. Rheumatologic or autoimmune disease.
9. Brain tumor or intracranial magnetic metallic implants.
10. History of epilepsy.
11. Periocular skin lesions.
12. Anxiety with Geriatric Anxiety Scale score \> 12.
13. History of claustrophobia.
14. Participation in another clinical trial within the past 3 months involving medication or training that could affect the eyes.
15. Physical or mental conditions that may increase the risk of participation or interfere with study assessments (e.g., dementia).
16. Previous ocular electrical stimulation treatment or visual training study within the past 12 months.
17. Uncontrolled hypertension or diabetes.
18. Pregnant or breastfeeding.
19. History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascular malformation, or intracranial surgery.

Where this trial is running

Taipei, Hawaii

• National Taiwan University Hospital — Taipei, Hawaii, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chien-Chia Su

Conditions Glaucoma; electrical stimulation