National Taiwan University Hospital
Taipei, Hawaii, 100, Taiwan
Location status: Recruiting
Location contact
Chien-Chia Su, MD., PhD
CONTACT
Yu-Cen Ma, MS
CONTACT
Recruiting
NCT Number: NCT07145073
Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- Previous ocular electrical stimulation treatment or visual training study within the past 12 months.
- Uncontrolled hypertension or diabetes.
- Pregnant or breastfeeding.
- History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascular malformation, or intracranial surgery.
Treatment and study plan
DC-Stimulator MC
DeviceExperimental：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment in hospital.
Primary outcomes
-
Change in visual field mean deviation (MD) from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Visual field testing will be performed with the Humphrey field analyzer
Secondary outcomes
-
Change in visual field mean deviation (MD) from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Visual field testing will be performed with the Humphrey field analyzer
-
Change in visual field mean deviation (MD) from baseline to post-treatment
Time frame: From treatment initiation to 19 days after treatment initiation
Visual field testing will be performed with the Humphrey field analyzer
-
Change in visual field mean deviation (MD) from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Visual field testing will be performed with the Humphrey field analyzer
-
Change in sensitivity at each of the 52 test points in the 24-2 visual field from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
-
Change in targeted mean deviation from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
-
Change in targeted mean deviation from baseline to post-treatment
Time frame: From treatment initiation to 19 days after treatment initiation
-
Change in targeted mean deviation from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
-
Change in targeted mean deviation from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Visual acuity measured by Landolt C Chart.
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Contrast sensitivity measured by CSV-1000
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Contrast sensitivity measured by MARS Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Color vision measured by HRR pseudoisochromatic test
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 5 days after treatment initiation
Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Visual acuity measured by Landolt C Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Contrast sensitivity measured by CSV-1000
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Contrast sensitivity measured by MARS Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Color vision measured by HRR pseudoisochromatic test
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation]
Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Visual acuity measured by Landolt C Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Contrast sensitivity measured by CSV-1000
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Contrast sensitivity measured by MARS Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Color vision measured by HRR pseudoisochromatic test
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Visual acuity measured by Landolt C Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Contrast sensitivity measured by CSV-1000
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Contrast sensitivity measured by MARS Contrast Sensitivity Chart
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Color vision measured by HRR pseudoisochromatic test
-
Visual function analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Vision-related quality of life assessed using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25). Scores are converted to a 0-100 scale, where higher scores indicate better vision-related quality of life.
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Health status assessed using the 36-Item Short Form Health Survey (SF-36). Scores for each domain and the overall score range from 0 to 100, where higher scores indicate better health status.
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Mobility in daily life assessed using the Mobility questionnaire. This questionnaire focuses on difficulties related to mobility and driving. Scores are reported on a 0-172 scale, where higher scores indicate greater difficulty with mobility and driving in daily life.
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Vision-related quality of life assessed using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25). Scores are converted to a 0-100 scale, where higher scores indicate better vision-related quality of life.
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Health status assessed using the 36-Item Short Form Health Survey (SF-36). Scores for each domain and the overall score range from 0 to 100, where higher scores indicate better health status.
-
Quality of life analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Mobility in daily life assessed using the Mobility questionnaire. This questionnaire focuses on difficulties related to mobility and driving. Scores are reported on a 0-172 scale, where higher scores indicate greater difficulty with mobility and driving in daily life.
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Macular ganglion cell-inner plexiform layer thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Optic nerve head cup-to-disc ratio (%)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Macular ganglion cell-inner plexiform layer thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Optic nerve head cup-to-disc ratio (%)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Macular ganglion cell-inner plexiform layer thickness (μm)
-
Optical coherence tomography (OCT) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Optic nerve head cup-to-disc ratio (%)
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Peripapillary vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
capillary density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Superficial density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
deep density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
foveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
parafoveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 12 days after treatment initiation
Foveal avascular zone (FAZ)
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Peripapillary vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
capillary density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Superficial density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
deep density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
foveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
parafoveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 26 days after treatment initiation
Foveal avascular zone (FAZ)
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Peripapillary vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
capillary density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Superficial density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
deep density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
foveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
parafoveal vessel density
-
Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment
Time frame: From treatment initiation to 166 days after treatment initiation
Foveal avascular zone (FAZ)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Official study title
Repetitive Transcranial Alternating Current Stimulation(rtACS) for the Treatment of Optic Neuropathies
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Aug 28, 2025
- Registry last updated
- Jan 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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