Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Glaucoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 3 sessions of 3 types of active brain stimulation and 1 session of placebo sham stimulation. Each participant will perform four sessions in a randomly-assigned order.Masking: Double (Participant, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

This study uses a within-subjects, double-blind, placebo-controlled design and will be carried out in Hong Kong (The Hong Kong Polytechnic University). Participants who will be recruited are 40 glaucoma patients aged 18 to 80, diagnosed with primary open-angle or normal-tension glaucoma with relativ...

This study uses a within-subjects, double-blind, placebo-controlled design and will be carried out in Hong Kong (The Hong Kong Polytechnic University). Participants who will be recruited are 40 glaucoma patients aged 18 to 80, diagnosed with primary open-angle or normal-tension glaucoma with relative scotoma in both eyes. All participants will take part in 4 stimulation sessions (completion of active a-tDCS, tACS, tRNS, and sham stimulation in random order) with at least 48-hour separation between visits to wash out active stimulation effects. The primary outcome is high-resolution perimetry that will be used to measure the visual field of participants. The secondary outcome is multifocal visual evoked potential (mfVEP) that will be used to measure the electrophysiological changes in the visual cortex. The study consists of 5 visits: Visit 1: Eligibility assessment (refer to the inclusion and exclusion criteria). Visits 2 - 5: Stimulation sessions (completion of active a-tDCS, tACS, tRNS, and sham stimulation in random order) with at least 48-hours separation between visits to wash out active stimulation effects. An established protocol will be used. Briefly, active a-tDCS (2 mA), tACS (2 mA), tRNS (2 mA) or sham a-tDCS will be delivered for 20 minutes. The anodal electrode will be placed at Oz (visual cortex) while the cathodal electrode will be placed on the left cheek to facilitate stimulation of cells corresponding to the para-central retina that are located within the calcarine sulcus. Active stimulation will involve the delivery of 2 mA current continuously, while the fade-in-short-stimulation-fade-out approach will be used for the sham condition, in which the stimulation will be ramped down after 30 seconds of stimulation. Both the participant and experimenter will be masked to the stimulation type. The average detection accuracy, response time, and functional connectivity will be analyzed using a within-subjects ANOVA with factors of Stimulation type (a-tDCS vs. tACS vs. tRNS vs. sham) and Time (pre and post-stimulation). Significant interactions will be investigated using post-hoc Bonferroni-adjusted paired sample t-tests. A significant interaction between Stimulation type and Time for the primary outcome followed by a significant post-hoc comparison with a p-value <0.05 favoring tRNS would be consistent with our hypothesis.

Tracking Information

NCT #
NCT04846140
Collaborators
  • Chinese University of Hong Kong
  • The University of Hong Kong
  • University of Waterloo
  • The Open University of Hong Kong
  • Otto-von-Guericke University Magdeburg
Investigators
Principal Investigator: Allen Cheong, PhD The Hong Kong Polytechnic University