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

NCT ID: NCT05874258

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-12-31

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).

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Real-PL + 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

Group Type: EXPERIMENTAL

Real-PL training + Real-tES(tDCS)

Intervention Type: OTHER

PLtraining : around 40mins, tDCS: 20mins

Real-PL + 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

Group Type: EXPERIMENTAL

Real-PL training + Sham-tES (tDCS)

Intervention Type: OTHER

PL training : around 40mins, tDCS: 20mins

Placebo-PL + 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

Group Type: PLACEBO_COMPARATOR

Placebo-PL training + Sham-tES (tDCS)

Intervention Type: OTHER

PL training : around 40mins, tDCS: 20mins

Interventions

Real-PL training + Real-tES(tDCS)

PLtraining : around 40mins, tDCS: 20mins

Intervention Type: OTHER

Real-PL training + Sham-tES (tDCS)

PL training : around 40mins, tDCS: 20mins

Intervention Type: OTHER

Placebo-PL training + Sham-tES (tDCS)

PL training : around 40mins, tDCS: 20mins

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: collaborator

University of Magdeburg

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Allen MY Cheong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Allen Cheong, PhD

Role: CONTACT

allen.my.cheong@polyu.edu.hk

852-27666108

Melinna Mei, PhD

Role: CONTACT

melinna.mei@polyu.edu.hk

852-34002309

Facility Contacts

Allen Cheong, PhD

Role: primary

allen.my.cheong@polyu.edu.hk

852-27666108

Melinna Mei, PhD

Role: backup

melinna.mei@polyu.edu.hk

852-34002309

References

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: 10.1186/s13063-024-08314-3.

Reference Type: DERIVED

PMID: 39039582 (View on PubMed)

Other Identifiers

HSEARS20190905001

Identifier Type: -

Identifier Source: org_study_id