Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies
NCT ID: NCT07145073
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
188 participants
INTERVENTIONAL
2025-12-08
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Electrical Stimulation for the Treatment of Optic Neuropathies
NCT05626426
A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
NCT03188042
Electrical Stimulation for the Treatment of Glaucoma
NCT05626491
Electrical Stimulation for Vision Neuroenhancement in Glaucoma
NCT06685211
Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.
NCT06693882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Repetitive Transcranial Alternating Current Stimulation treatment
Participants will receive 10 days of repeated transcranial alternating current stimulation in hospital.
DC-Stimulator MC
Experimental：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment in hospital.
Sham Repetitive Transcranial Alternating Current Stimulation
Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.
DC-Stimulator MC
Sham Comparator：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DC-Stimulator MC
Experimental：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment in hospital.
DC-Stimulator MC
Sham Comparator：Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, Hawaii, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202409124DSE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.