Glaucoma Rehabilitation Using ElectricAI Transcranial Stimulation (GREAT) - Randomized Controlled Trial Using Combined Perceptual Learning and Transcranial Electrical Stimulation for Vision Enhancement

Официальное название

Improving Vision and Quality of Life in Patients With Glaucoma Using Non-invasive Brain Stimulation and Perceptual Learning: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Real-PL training + Real-tES(tDCS)
  PLtraining : around 40mins, tDCS: 20mins
• Другое Real-PL training + Sham-tES (tDCS)
  PL training : around 40mins, tDCS: 20mins
• Другое Placebo-PL training + Sham-tES (tDCS)
  PL training : around 40mins, tDCS: 20mins

Первичные конечные точки

• Visual field test [Срок оценки: 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]

Вторичные конечные точки (5)

• High Resolution Perimetry (HRP) [Срок оценки: 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]
• Electroencephalography (EEG) [Срок оценки: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks]
• Gait Test [Срок оценки: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks]
• Balance function [Срок оценки: 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]
• Questionnaires for QoL [Срок оценки: Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Публикации

• Jia S, Mei X, Chen L, Chan LH, Tsang C, Suen V, Li T, Zaw MW, Liu A, Thompson B, Sabel B, Woo G, Leung CKS, Yip SP, Chang DHF, Cheong AMY. Glaucoma Rehabilitation using ElectricAI Transcranial Stimulation (GREAT)-study protocol for randomized controlled trial using combined perceptual learning and transcranial electrical stimulation for vision enhancement. Trials. 2024 Jul 22;25(1):501. doi: 10.11 PMID 39039582

Идентификаторы

NCT: NCT05874258 · HSEARS20190905001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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