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Not Yet RecruitingNCT07486323

Combined Non-Invasive Brain and Visual Stimulation for Vision Improvement

Evaluation of Combined Non-invasive Brain Stimulation (NIBS) and Visual Tetanic Stimulation (VTS) for Vision Enhancement: A Randomized, Single-blind, Cross-over Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
56 (estimated)
Sponsor
The Hong Kong Polytechnic University · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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. This study will examine the effect of transcranial direct current stimulation (NIBS) on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma.

Detailed description

This study uses a prospective, single-masked, randomized, cross-over, placebo-controlled training RCT design. The eligible participants will be randomly allocated into 4 groups: (A) Transcranial direct current stimulation; (B) Visual Tetanic Stimulation; (C) Transcranial direct current stimulation+ Visual Tetanic Stimulation; (D) Sham. All participants will underwent all the 4 types of intervention with a 14 days washing out period between intervention types: All participants will complete twenty-six study visits: Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2: Outcome measures (Pre-intervention/ baseline); Visit 3-7: 5 sessions intervention (1st intervention block); Visit 8: Post 1 outcome measures; Visit 9-13: 5 sessions intervention (2nd intervention block); Visit 14: Post 2 outcome measures; Visit 15-19: 5 sessions intervention (3rd intervention block); Visit 20: Post 3 outcome measures; Visit 21-25: 5 sessions intervention (4th intervention block); Visit 26: Post 4 outcome measures Eight sessions of assessment will be conducted: (1) Baseline-1; (2) Post-1 (after 5-sessions training); (3) Baseline-2; (4) Post-2 (after 5-sessions training); (5) Baseline-3; (6) Post-3 (after 5-sessions training); (7) Baseline-4; and (8) Post-4 (after 5-sessions training).

Conditions

Interventions

TypeNameDescription
OTHERNIBSAround 1 hour
OTHERVTSAround 1 hour
OTHERNIBS+VTSAround 1 hour
OTHERShamAround 1 hour

Timeline

Start date
2026-04-20
Primary completion
2027-06-30
Completion
2027-07-10
First posted
2026-03-20
Last updated
2026-03-24

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07486323. Inclusion in this directory is not an endorsement.