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GlaucomaNCT07145073

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

A study testing DC-Stimulator MC in people with Glaucoma, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
What is being tested?
DC-Stimulator MC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
1 siteTaiwan
Study dates
26 Jan 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu-Cen Ma contact

s431075656@gmail.com

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, Hawaii, 100

    Chien-Chia Su, MD., PhD, 886972653340, chienchiasu@ntu.edu.tw

    Yu-Cen Ma, MS, 886903028820, s431075656@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Conditions
Glaucoma
Being tested
DC-Stimulator MC
Keywords
Glaucoma, electrical stimulation
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC-Stimulator MCDevice

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

  • DC-Stimulator MCDevice

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

Study groups in NCT07145073
Study groupRoleWhat they receive
Repetitive Transcranial Alternating Current Stimulation treatmentExperimentalParticipants will receive 10 days of repeated transcranial alternating current stimulation in hospital.
Receives: Device: DC-Stimulator MC
Sham Repetitive Transcranial Alternating Current StimulationSham comparatorParticipants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.
Receives: Device: DC-Stimulator MC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Visual field testing will be performed with the Humphrey field analyzer

    Measured: From treatment initiation to 26 days after treatment initiation

Secondary outcomes (68)
  1. Change in visual field mean deviation (MD) from baseline to post-treatment

    Visual field testing will be performed with the Humphrey field analyzer

    Measured: From treatment initiation to 12 days after treatment initiation

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

    Visual field testing will be performed with the Humphrey field analyzer

    Measured: From treatment initiation to 19 days after treatment initiation

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

    Visual field testing will be performed with the Humphrey field analyzer

    Measured: From treatment initiation to 166 days after treatment initiation

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

    Measured: From treatment initiation to 26 days after treatment initiation

  5. Change in targeted mean deviation from baseline to post-treatment

    Measured: From treatment initiation to 12 days after treatment initiation

  6. Change in targeted mean deviation from baseline to post-treatment

    Measured: From treatment initiation to 19 days after treatment initiation

  7. Change in targeted mean deviation from baseline to post-treatment

    Measured: From treatment initiation to 26 days after treatment initiation

  8. Change in targeted mean deviation from baseline to post-treatment

    Measured: From treatment initiation to 166 days after treatment initiation

  9. Visual function analysis from baseline to post-treatment

    Visual acuity measured by Landolt C Chart.

    Measured: From treatment initiation to 5 days after treatment initiation

  10. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by CSV-1000

    Measured: From treatment initiation to 5 days after treatment initiation

  11. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart

    Measured: From treatment initiation to 5 days after treatment initiation

  12. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by MARS Contrast Sensitivity Chart

    Measured: From treatment initiation to 5 days after treatment initiation

  13. Visual function analysis from baseline to post-treatment

    Color vision measured by HRR pseudoisochromatic test

    Measured: From treatment initiation to 5 days after treatment initiation

  14. Visual function analysis from baseline to post-treatment

    Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)

    Measured: From treatment initiation to 5 days after treatment initiation

  15. Visual function analysis from baseline to post-treatment

    Visual acuity measured by Landolt C Chart

    Measured: From treatment initiation to 12 days after treatment initiation

  16. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by CSV-1000

    Measured: From treatment initiation to 12 days after treatment initiation

  17. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart

    Measured: From treatment initiation to 12 days after treatment initiation

  18. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by MARS Contrast Sensitivity Chart

    Measured: From treatment initiation to 12 days after treatment initiation

  19. Visual function analysis from baseline to post-treatment

    Color vision measured by HRR pseudoisochromatic test

    Measured: From treatment initiation to 12 days after treatment initiation

  20. Visual function analysis from baseline to post-treatment

    Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)

    Measured: From treatment initiation to 12 days after treatment initiation]

  21. Visual function analysis from baseline to post-treatment

    Visual acuity measured by Landolt C Chart

    Measured: From treatment initiation to 26 days after treatment initiation

  22. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by CSV-1000

    Measured: From treatment initiation to 26 days after treatment initiation

  23. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart

    Measured: From treatment initiation to 26 days after treatment initiation

  24. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by MARS Contrast Sensitivity Chart

    Measured: From treatment initiation to 26 days after treatment initiation

  25. Visual function analysis from baseline to post-treatment

    Color vision measured by HRR pseudoisochromatic test

    Measured: From treatment initiation to 26 days after treatment initiation

  26. Visual function analysis from baseline to post-treatment

    Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)

    Measured: From treatment initiation to 26 days after treatment initiation

  27. Visual function analysis from baseline to post-treatment

    Visual acuity measured by Landolt C Chart

    Measured: From treatment initiation to 166 days after treatment initiation

  28. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by CSV-1000

    Measured: From treatment initiation to 166 days after treatment initiation

  29. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by Pelli-Robson Contrast Sensitivity Chart

    Measured: From treatment initiation to 166 days after treatment initiation

  30. Visual function analysis from baseline to post-treatment

    Contrast sensitivity measured by MARS Contrast Sensitivity Chart

    Measured: From treatment initiation to 166 days after treatment initiation

  31. Visual function analysis from baseline to post-treatment

    Color vision measured by HRR pseudoisochromatic test

    Measured: From treatment initiation to 166 days after treatment initiation

  32. Visual function analysis from baseline to post-treatment

    Continuous Chinese reading acuity measured by Paragraph Chinese Reading Acuity Test (P-CRAT)

    Measured: From treatment initiation to 166 days after treatment initiation

  33. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 12 days after treatment initiation

  34. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 12 days after treatment initiation

  35. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 12 days after treatment initiation

  36. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 166 days after treatment initiation

  37. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 166 days after treatment initiation

  38. Quality of life analysis from baseline to post-treatment

    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.

    Measured: From treatment initiation to 166 days after treatment initiation

  39. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)

    Measured: From treatment initiation to 12 days after treatment initiation

  40. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Macular ganglion cell-inner plexiform layer thickness (μm)

    Measured: From treatment initiation to 12 days after treatment initiation

  41. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Optic nerve head cup-to-disc ratio (%)

    Measured: From treatment initiation to 12 days after treatment initiation

  42. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)

    Measured: From treatment initiation to 26 days after treatment initiation

  43. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Macular ganglion cell-inner plexiform layer thickness (μm)

    Measured: From treatment initiation to 26 days after treatment initiation

  44. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Optic nerve head cup-to-disc ratio (%)

    Measured: From treatment initiation to 26 days after treatment initiation

  45. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Peripapillary retinal nerve fiber layer (RNFL) thickness (μm)

    Measured: From treatment initiation to 166 days after treatment initiation

  46. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Macular ganglion cell-inner plexiform layer thickness (μm)

    Measured: From treatment initiation to 166 days after treatment initiation

  47. Optical coherence tomography (OCT) analysis from baseline to post-treatment

    Optic nerve head cup-to-disc ratio (%)

    Measured: From treatment initiation to 166 days after treatment initiation

  48. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Peripapillary vessel density

    Measured: From treatment initiation to 12 days after treatment initiation

  49. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    capillary density

    Measured: From treatment initiation to 12 days after treatment initiation

  50. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Superficial density

    Measured: From treatment initiation to 12 days after treatment initiation

  51. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    deep density

    Measured: From treatment initiation to 12 days after treatment initiation

  52. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    foveal vessel density

    Measured: From treatment initiation to 12 days after treatment initiation

  53. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    parafoveal vessel density

    Measured: From treatment initiation to 12 days after treatment initiation

  54. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Foveal avascular zone (FAZ)

    Measured: From treatment initiation to 12 days after treatment initiation

  55. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Peripapillary vessel density

    Measured: From treatment initiation to 26 days after treatment initiation

  56. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    capillary density

    Measured: From treatment initiation to 26 days after treatment initiation

  57. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Superficial density

    Measured: From treatment initiation to 26 days after treatment initiation

  58. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    deep density

    Measured: From treatment initiation to 26 days after treatment initiation

  59. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    foveal vessel density

    Measured: From treatment initiation to 26 days after treatment initiation

  60. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    parafoveal vessel density

    Measured: From treatment initiation to 26 days after treatment initiation

  61. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Foveal avascular zone (FAZ)

    Measured: From treatment initiation to 26 days after treatment initiation

  62. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Peripapillary vessel density

    Measured: From treatment initiation to 166 days after treatment initiation

  63. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    capillary density

    Measured: From treatment initiation to 166 days after treatment initiation

  64. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Superficial density

    Measured: From treatment initiation to 166 days after treatment initiation

  65. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    deep density

    Measured: From treatment initiation to 166 days after treatment initiation

  66. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    foveal vessel density

    Measured: From treatment initiation to 166 days after treatment initiation

  67. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    parafoveal vessel density

    Measured: From treatment initiation to 166 days after treatment initiation

  68. Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment

    Foveal avascular zone (FAZ)

    Measured: From treatment initiation to 166 days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start26 Jan 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145073
Sponsor's protocol ID
202409124DSE
Status last verified
Aug 2025
First submitted
11 Aug 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing DC-Stimulator MC in people with Glaucoma, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chien-Chia Su (+886 972653340, chienchiasu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visual field mean deviation (MD) from baseline to post-treatment (time frame: From treatment initiation to 26 days after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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