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Not yet recruitingNCT07486323Updated Mar 24, 2026

Combined Non-Invasive Brain and Visual Stimulation for Vision Improvement

An interventional study of NIBS and VTS in Glaucoma Open-Angle, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

Glaucoma is a complex disease that can result in progressive vision loss. It is the second leading cause of blindness, accounting for 23% of permanent blindness in Hong Kong. There are no treatments that restore vision lost to glaucoma. This study will examine the effect of transcranial direct current stimulation (NIBS) on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma.

Read the detailed description

This study uses a prospective, single-masked, randomized, cross-over, placebo-controlled training RCT design.

The eligible participants will be randomly allocated into 4 groups:

(A) Transcranial direct current stimulation; (B) Visual Tetanic Stimulation; (C) Transcranial direct current stimulation+ Visual Tetanic Stimulation; (D) Sham. All participants will underwent all the 4 types of intervention with a 14 days washing out period between intervention types:

All participants will complete twenty-six study visits:

Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2: Outcome measures (Pre-intervention/ baseline); Visit 3-7: 5 sessions intervention (1st intervention block); Visit 8: Post 1 outcome measures; Visit 9-13: 5 sessions intervention (2nd intervention block); Visit 14: Post 2 outcome measures; Visit 15-19: 5 sessions intervention (3rd intervention block); Visit 20: Post 3 outcome measures; Visit 21-25: 5 sessions intervention (4th intervention block); Visit 26: Post 4 outcome measures

Eight sessions of assessment will be conducted: (1) Baseline-1; (2) Post-1 (after 5-sessions training); (3) Baseline-2; (4) Post-2 (after 5-sessions training); (5) Baseline-3; (6) Post-3 (after 5-sessions training); (7) Baseline-4; and (8) Post-4 (after 5-sessions training).

02

Conditions studied

  • Glaucoma Open-Angle

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Keywords

  • tDCS
  • transcranial electrical stimulation
  • visual tetanic stimulation
  • alpha frequency stimulation
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 56 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age range from 18 to 80 years;
  • Diagnosis of primary open angle or normal tension glaucoma with relative scotoma in both eyes;
  • A relative scotoma defined as a Humphrey Field Analyser (HFA) threshold perimetry loss (mean deviation of -6dB) within the central 24 degree of the visual field for at least one eye;
  • Best-corrected distance visual acuity of 6/12 or better (equivalent to 0.3 logMAR acuity or better to confirm that participant's central vision is preserved).
  • Stable vision and visual field loss for at least 3 months;
  • With a cognitive functional score of 22 or above in the - Hong Kong version (HK-MoCA) (to confirm participant's intact cognitive function).

Exclusion criteria

Exclusion Criteria:

  • Ocular diseases other than glaucoma (e.g. age-related macular degeneration, diabetic retinopathy, moderate to severe cataract) or severe hearing impairment (to ensure that participant can hear the instructions clearly during assessments and training);
  • Severe medical problems (e.g. stroke, Parkinson's disease) or self-reported neurological (e.g. brain surgery, brain tumor, peripheral neuropathy), or cognitive disorders (e.g. diagnosed dementia or cognitive impairment);
  • Self-reported vestibular or cerebellar dysfunction, history of vertigo;
  • Using any medications for any neurological conditions or psychiatric drugs (e.g. sedative, hypnotic) that might interfere motor control;
  • for non-invasive brain stimulation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Visual Tetanic Stimulation (VTS)

    Participant will receive 5 training sessions with VTS: about 1 hour per session

    Other: VTS

  • Active comparator
    Transcranial direct current stimulation (NIBS)

    Participant will receive 5 training sessions with NIBS: about 1 hour per session

    Other: NIBS

  • Experimental
    Transcranial direct current stimulation+ Visual Tetanic Stimulation (NIBS+VTS)

    Participant will receive 5 training sessions with NIBS+VTS: about 1 hour per session

    Other: NIBS+VTS

  • Placebo comparator
    Sham

    Participant will receive 5 training sessions with Sham: about 1 hour per session

    Other: Sham

Interventions

  • OtherNIBS

    Around 1 hour

  • OtherVTS

    Around 1 hour

  • OtherNIBS+VTS

    Around 1 hour

  • OtherSham

    Around 1 hour

06

What researchers measure

Primary outcomes

  1. Visual field test

    Visual field test is measured monocularly using the 24-2 Swedish interactive threshold algorithm (SITA) standard tests by Humphrey visual field analyzer (HFA, Carl Zeiss Meditec Inc., California). The mean deviation (MD), pattern standard deviation (PSD), and visual field index (VFI) are recorded, and the MD of the 24-2 visual field test will be used as the primary outcome of intervention effect.

    Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)

  2. Electroencephalography (EEG)

    Electrophysiological function is assessed using a 64-channel high-resolution electroencephalography (EEG) system. EEG outcome measures include spectral power in the delta, theta, alpha, beta, and gamma frequency bands, with particular focus on alpha-band activity, as well as functional connectivity measures derived from scalp EEG recordings, including coherence, phase-based connectivity, and related network indices. Pattern-reversal visual evoked potentials (PR-VEP) are recorded during presentation of a high-contrast checkerboard stimulus to the central 20-degree visual field under monocular viewing conditions. Stimuli are presented at 0.5 Hz and 1.5 Hz with 40 reversals. PR-VEP outcome measures include N75 latency, P100 latency, N135 latency, and N75-P100 and/or P100-N135 amplitude.

    Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)

  3. Optical Coherence Tomography (OCT)

    Retinal nerve fiber layer is measured using spectral-domain Optical Coherence Tomography (OCT). Peripapillary retinal nerve fiber layer thickness is obtained from a circular scan centered on the optic nerve head. Ganglion cell thickness is measure using macular OCT imaging

    Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)

  4. Optical Coherence Tomography Angiography (OCT-A)

    Evaluation of retinal vascular function in glaucoma patients is measured. Detailed visualisation of microvasculature structure within the retina and optic nerve head is measured, change of ocular perfusion is shown.

    Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this study will be shared via the Open Science Framework (OSF). These data will include participant-level demographic and clinical characteristics, baseline assessments, intervention-related variables, and primary and secondary outcome data necessary to reproduce the reported analyses. Supporting documents, including the study protocol, statistical analysis plan, data dictionary, and study materials, will also be made available on OSF.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: De-identified individual participant data and supporting documents will be made available beginning within 6 months after publication of the primary study results and will remain available indefinitely on the Open Science Framework (OSF).

Access criteria: will be publicly available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07486323
Responsible party
Allen MY Cheong (Assoc. Head (Academic Programmes and Clinical Training), Prog. Leader [BSc (Hons) in Optometry; MSc in Vision Science and Innovation] & Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Mar 20, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 10, 2027 (estimated)
Last update
Mar 24, 2026

Study contacts

Ming Yan Cheong, PhD
Contact
allen.my.cheong@polyu.edu.hk
852-27666108
Lok Hin Chan, BSc (Hons) in Optometry
Contact
lhinchan@polyu.edu.hk
852-34002309

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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