Clinical trial NCT05874258: Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) - Randomized Controlled Trial Using Combined Perceptual Learning and Transcranial Electrical Stimulation for Vision Enhancement
Official title: Improving Vision and Quality of Life in Patients With Glaucoma Using Non-invasive Brain Stimulation and Perceptual Learning: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
transcranial direct current stimulation (tDCS)
perceptual learning (PL)
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: University of Waterloo
name: University of Magdeburg
First posted: 2023-05-24
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A prospective, double-masked, randomized, placebo-controlled training RCT design
Primary purpose: SUPPORTIVE_CARE

Brief 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. However, recent studies have shown that vision can be improved by perceptual learning (PL) and transcranial electrical stimulation (tES). This study will examine the effect of perceptual learning and tES on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma. It is phase 2 of Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) project.

Detailed description: Study design:

This study uses a prospective, double-masked, randomized, placebo-controlled training RCT design.

The eligible participants will be randomly allocated into 3 groups:

(A) Placebo-Perceptual learning + Sham-tES; (B) Real-Perceptual learning + Sham-tES; (C) Real-Perceptual learning + Real-tES.

All participants will complete forty-three study visits:

Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2-3: Outcome measures (Pre-intervention/ baseline); Visit 4-13: 10 sessions intervention (1st batch); Visit 14-15: Interim 1 Outcome measures; Visit 16-25: 10 sessions intervention (2nd batch); Visit 26-27: Interim 2 Outcome measures; Visit 28-37: 10 sessions intervention (3rd batch); Visit 38-39: Post-training 1 Outcome measures; Visit 40-41: Post-training 2 Outcome measures (to evaluate the retention effect after 1 month); Visit 42-43: Post-training 3 Outcome measures (to evaluate the retention effect after 2 months).

Six sessions of assessment will be conducted: (1) Baseline; (2) Interim-1 (after 10-sessions training); (3) Interim-2 (after 20-sessions training); (4) Post-1 (after 30-sessions training); (5) Post-2 (1-month post training); and (6) Post-3 (2-month post training).

Eligibility criteria: 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 Montreal Cognitive Assessment - Hong Kong version (HK-MoCA) (to confirm participant's intact cognitive function).

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;
* Contraindications for non-invasive brain stimulation.

Primary outcomes:
measure: Visual field test
timeFrame: Change from baseline at 5weeks, change from baseline at 10weeks, change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
Secondary outcomes:
measure: High Resolution Perimetry (HRP)
timeFrame: Change from baseline at 5weeks, change from baseline at 10weeks, change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
measure: Electroencephalography (EEG)
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
measure: Gait Test
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
measure: Balance function
timeFrame: Change from baseline at 5weeks, change from baseline at 10weeks, change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
measure: Questionnaires for QoL
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
Other outcomes:
measure: Magnetic resonance spectroscopy (Optional)
timeFrame: Change from baseline at 15 weeks
measure: BDNF concentration in serum and tears (Optional)
timeFrame: Change from baseline at 15 weeks
measure: Cortisol concentration in serum and tears (Optional)
timeFrame: Change from baseline at 15 weeks
measure: Questionnaire of psychological state
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, change from baseline at 23weeks.
measure: Questionnaire of fear of falling
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, change from baseline at 23weeks.
measure: Kinetic visual field
timeFrame: Change from baseline at 15weeks, change from baseline at 19weeks, change from baseline at 23weeks.
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: