Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) - Randomized Controlled Trial Using Combined Perceptual Learning and Transcranial Electrical Stimulation for Vision Enhancement
- Conditions
- Glaucoma
- Interventions
- Other: Real-PL training + Sham-tES (tDCS)Other: Real-PL training + Real-tES(tDCS)Other: Placebo-PL training + Sham-tES (tDCS)
- Registration Number
- NCT05874258
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Real-PL + Sham-tES (tDCS) Real-PL training + Sham-tES (tDCS) Participant will receive 30 training sessions with real PL and sham tES (tDCS): 3-4 sessions per week, about 1 hour per session Real-PL + Real-tES (tDCS) Real-PL training + Real-tES(tDCS) Participant will receive 30 training sessions with real PL and real tES (tDCS): 3-4 sessions per week, about 1 hour per session Placebo-PL + Sham-tES (tDCS) Placebo-PL training + Sham-tES (tDCS) Participant will receive 30 training sessions with placebo PL and sham tES (tDCS): 3-4 sessions per week , about 1 hour per session
- Primary Outcome Measures
Name Time Method Visual field test 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 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 24-2 visual field test is used as primary outcome of intervention effectiveness.
- Secondary Outcome Measures
Name Time Method Questionnaires for QoL Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25) and Low Vision Quality of Life (LVQoL) will be used to evaluate the patient-perceived outcome of the intervention on daily living. In NEI-VFQ 25, more positive person measures indicates greater visual ability, and more negative person measures have less visual ability. In the LVQoL, the completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).
Electroencephalography (EEG) Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks 64-channel electroencephalography(EEG) recordings from Neuroscan will be used to understand the electrophysiological changes in the intervention. A standard visual evoked potential task (VEP) and a specific designed SSVEP task will be used to assess the functional integrity of central vision and peripheral function. Besides, resting-state EEG will be recorded to measure the functional connectivity at different timepoints. ERP components (such as P100, N1 and N2) in VEP, tagging frequency response in SSVEP, and the power correlation in resting state will be analyzed as physiological indicators.
High Resolution Perimetry (HRP) 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 The current HRP is a valid and reliable computer-based visual field assessment based upon a previously well-established program. The revised HRP uses circular geometry instead of a rectangle to present stimuli, while maintaining its high-resolution advantage. During the HRP test, suprathreshold stimuli are presented in a radial pattern within 20 degrees, with a step size of 3 degrees. These stimuli are presented monocularly at a total of 98 positions, with the order of presentation randomized. To ensure a stable result and accurate assessment of participants' responses, the HRP test is repeated five times. Throughout the HRP test, fixation is monitored by an infrared eye tracker (SR Research, Eyelink Portable Duo).
Gait Test Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks All participants will be asked to walk along a 7-m walkway at their normal pace. Two disturbing factors will be introduced while walking: visual searching task and obstacle crossing. For trials with visual search, visual stimuli will be presented on the monitor (located at the end of the walkway) when the participant crosses the obstacle. For trials with obstacle crossing, an obstacle with two different colors (grey for low contrast and yellow for high contrast obstacle) of two different heights (2.5x60x5 cm or 2.5x60x15 cm) are positioned at the middle of the walkway. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), head flexion/extension (degree), walking speed (mm/s), step width (mm), and toe clearance(mm) will be measured and analyzed for each condition.
Balance function 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 Balance function will be evaluated for the following two conditions:
1. Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
2. Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
🇭🇰Hong Kong, Hong Kong