Combined Non-Invasive Brain and Visual Stimulation for Vision Improvement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • NIBS

    Other intervention

    Around 1 hour

  • VTS

    Other intervention

    Around 1 hour

  • NIBS+VTS

    Other intervention

    Around 1 hour

  • Sham

    Other intervention

    Around 1 hour

Treatment groups

56 Participants
are divided into 4 treatment groups
Group A: Visual Tetanic Stimulation (VTS)Experimental treatment 1 intervention
Group B: Transcranial direct current stimulation (NIBS)Active comparator 1 intervention
Group C: Transcranial direct current stimulation+ Visual Tetanic Stimulation (NIBS+VTS)Experimental treatment 1 intervention
Group D: ShamPlacebo comparator 1 intervention

Trial outcomes

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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