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

NCT07145073 | Recruiting

• 1 other identifier: 202409124DSE
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to see whether repeated transcranial alternating current stimulation can activate impaired retinal ganglion cells and improve both structural and functional outcomes in patients with glaucoma.

Conditions

Glaucoma

Keywords

Glaucoma; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Change in visual field mean deviation (MD) from baseline to post-treatment

  Visual field testing will be performed with the Humphrey field analyzer

  From treatment initiation to 26 days after treatment initiation

Secondary Outcomes (68)

• Change in visual field mean deviation (MD) from baseline to post-treatment

  From treatment initiation to 12 days after treatment initiation

• Change in visual field mean deviation (MD) from baseline to post-treatment

  From treatment initiation to 19 days after treatment initiation

• Change in visual field mean deviation (MD) from baseline to post-treatment

  From treatment initiation to 166 days after treatment initiation

• Change in sensitivity at each of the 52 test points in the 24-2 visual field from baseline to post-treatment

  From treatment initiation to 26 days after treatment initiation

• Change in targeted mean deviation from baseline to post-treatment

  From treatment initiation to 12 days after treatment initiation

Study Arms (2)

Repetitive Transcranial Alternating Current Stimulation treatment

EXPERIMENTAL

Participants will receive 10 days of repeated transcranial alternating current stimulation in hospital.

Device: DC-Stimulator MC

Sham Repetitive Transcranial Alternating Current Stimulation

SHAM COMPARATOR

Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.

Device: DC-Stimulator MC

Interventions

DC-Stimulator MC DEVICE

Experimental：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment in hospital.

Repetitive Transcranial Alternating Current Stimulation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of ocular herpes.
• Pathological nystagmus.
• Retinal disease sufficient to affect vision.
• Corneal opacity affecting vision.
• Cataract affecting vision.
• Uveitis or other intraocular inflammatory disease.
• Implanted electronic devices such as a pacemaker.
• Rheumatologic or autoimmune disease.
• Brain tumor or intracranial magnetic metallic implants.
• History of epilepsy.
• Periocular skin lesions.
• Anxiety with Geriatric Anxiety Scale score \> 12.
• History of claustrophobia.
• Participation in another clinical trial within the past 3 months involving medication or training that could affect the eyes.
• Physical or mental conditions that may increase the risk of participation or interfere with study assessments (e.g., dementia).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Hawaii, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Chien-Chia Su

CONTACT

+886 972653340; chienchiasu@ntu.edu.tw

Yu-Cen Ma

CONTACT

s431075656@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 28, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2025-08

Locations

TW (1)