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

NCT05874258 | Recruiting

• 1 other identifier: HSEARS20190905001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; transcranial direct current stimulation (tDCS); perceptual learning (PL)

Outcome Measures

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 24-2 visual field test is used as primary outcome of intervention effectiveness.

  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 (5)

• 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

• Electroencephalography (EEG)

  Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks

• Gait Test

  Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks

• 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

• Questionnaires for QoL

  Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks

Other Outcomes (6)

• Magnetic resonance spectroscopy (Optional)

  Change from baseline at 15 weeks

• BDNF concentration in serum and tears (Optional)

  Change from baseline at 15 weeks

• Cortisol concentration in serum and tears (Optional)

  Change from baseline at 15 weeks

Study Arms (3)

Real-PL + Real-tES (tDCS)

EXPERIMENTAL

Participant will receive 30 training sessions with real PL and real tES (tDCS): 3-4 sessions per week, about 1 hour per session

Other: Real-PL training + Real-tES(tDCS)

Real-PL + Sham-tES (tDCS)

EXPERIMENTAL

Participant will receive 30 training sessions with real PL and sham tES (tDCS): 3-4 sessions per week, about 1 hour per session

Other: Real-PL training + Sham-tES (tDCS)

Placebo-PL + Sham-tES (tDCS)

PLACEBO COMPARATOR

Participant will receive 30 training sessions with placebo PL and sham tES (tDCS): 3-4 sessions per week , about 1 hour per session

Other: Placebo-PL training + Sham-tES (tDCS)

Interventions

Real-PL training + Real-tES(tDCS) OTHER

PLtraining : around 40mins, tDCS: 20mins

Real-PL + Real-tES (tDCS)

Real-PL training + Sham-tES (tDCS) OTHER

PL training : around 40mins, tDCS: 20mins

Real-PL + Sham-tES (tDCS)

Placebo-PL training + Sham-tES (tDCS) OTHER

PL training : around 40mins, tDCS: 20mins

Placebo-PL + Sham-tES (tDCS)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator
• University of Waterloo: collaborator
• University of Magdeburg: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 39039582 DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Allen Cheong, PhD

CONTACT

852-27666108; allen.my.cheong@polyu.edu.hk

Melinna Mei, PhD

CONTACT

852-34002309; melinna.mei@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masked investigators responsible for all outcome measures and unmasked investigators responsible for group allocation and intervention. A set of random numbers will be generated by computer and the simple random sampling method (which matches according to age and gender) will be used to allocate the eligible participants into 3 groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, double-masked, randomized, placebo-controlled training RCT design

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 24, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: available: 3mths after data complication
• Access Criteria: The requestor's affiliation and purpose are required to get the access.

Locations

HK (1)