Back to resultsEffectiveness of NIBS and Perceptual Learning for Improving Visual Performance in Patients With Glaucoma
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Real-PL training + Real-NIBS(tDCS)
Real-PL training + Sham-NIBS (tDCS)
Placebo-PL training + Sham-NIBS (tDCS)
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring glaucoma, transcranial direct current stimulation (tDCS), perceptual learning (PL)
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.
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Real-PL + Real-NIBS (tDCS)
Real-PL + Sham-NIBS (tDCS)
Placebo-PL + Sham-NIBS (tDCS)
Arm Description
Participant will receive 30 training sessions with real PL and real NIBS (tDCS): 3-4 sessions per week, about 1 hour per session
Participant will receive 30 training sessions with real PL and sham NIBS (tDCS): 3-4 sessions per week, about 1 hour per session
Participant will receive 30 training sessions with placebo PL and sham NIBS (tDCS): 3-4 sessions per week , about 1 hour per session
Outcomes
Primary Outcome Measures
Peripheral visual function (high-resolution perimetry & conventional perimetry)
Peripheral visual function will be evaluated monocularly by high-resolution perimetry (HRP) along with conventional perimetry using the program SITA-Standard 24-2 of the HFA. These are two common outcome measures adopted in previous glaucoma RCTs
Electroencephalography (EEG)
64-channel electroencephalography(EEG) recordings from Neuroscan will be used to understand the electrophysiological changes in the intervention. A standard visual evoked potential task (VEP) and a specific designed SSVEP task will be used to assess the functional integrity of central vision and peripheral function. Besides, resting-state EEG will be recorded to measure the functional connectivity at different timepoints. ERP components (such as P100, N1 and N2) in VEP, tagging frequency response in SSVEP, and the power correlation in resting state will be analyzed as physiological indicators.
Secondary Outcome Measures
Questionnaires for QoL
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25) and Low Vision Quality of Life (LVQoL) will be used to evaluate the patient-perceived outcome of the intervention on daily living. In NEI-VFQ 25, more positive person measures indicates greater visual ability, and more negative person measures have less visual ability. In the LVQoL, the completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).
Balance function
Balance function will be evaluated for the following two conditions:
Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Gait Test
All participants will be asked to walk along a 7-m walkway at their normal pace. Two disturbing factors will be introduced while walking: visual searching task and obstacle crossing. For trials with visual search, visual stimuli will be presented on the monitor (located at the end of the walkway) when the participant crosses the obstacle. For trials with obstacle crossing, an obstacle with two different colors (grey for low contrast and yellow for high contrast obstacle) of two different heights (2.5x60x5 cm or 2.5x60x15 cm) are positioned at the middle of the walkway. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), head flexion/extension (degree), walking speed (mm/s), step width (mm), and toe clearance(mm) will be measured and analyzed for each condition.
Questionnaire of psychological state
Perceived Stress Scale (PSS-10) and Patient Health Questionnaire - 9 (PHQ9) will be used to evaluated the stress and depression severity of the outcome of the intervention of participant. Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress. In PHQ9, the completion results in a summed score between 0 (none minimal) to 27 (severe).
Full Information
NCT ID
NCT05874258
First Posted
May 3, 2023
Last Updated
August 6, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong, University of Waterloo, University of Magdeburg
1. Study Identification
Unique Protocol Identification Number
NCT05874258
Brief Title
Effectiveness of NIBS and Perceptual Learning for Improving Visual Performance in Patients With Glaucoma
Official Title
Improving Vision and Quality of Life in Patients With Glaucoma Using Non-invasive Brain Stimulation and Perceptual Learning: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong, University of Waterloo, University of Magdeburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 non-invasive brain stimulation (NIBS) and visual training. This study will examine the effect of perceptual learning and NIBS on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma.
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-NIBS; (B) Real-Perceptual learning + Sham-NIBS; (C) Real-Perceptual learning + Real-NIBS.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, transcranial direct current stimulation (tDCS), perceptual learning (PL)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A prospective, double-masked, randomized, placebo-controlled training RCT design
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real-PL + Real-NIBS (tDCS)
Arm Type
Experimental
Arm Description
Participant will receive 30 training sessions with real PL and real NIBS (tDCS): 3-4 sessions per week, about 1 hour per session
Arm Title
Real-PL + Sham-NIBS (tDCS)
Arm Type
Experimental
Arm Description
Participant will receive 30 training sessions with real PL and sham NIBS (tDCS): 3-4 sessions per week, about 1 hour per session
Arm Title
Placebo-PL + Sham-NIBS (tDCS)
Arm Type
Placebo Comparator
Arm Description
Participant will receive 30 training sessions with placebo PL and sham NIBS (tDCS): 3-4 sessions per week , about 1 hour per session
Intervention Type
Other
Intervention Name(s)
Real-PL training + Real-NIBS(tDCS)
Intervention Description
PLtraining : around 40mins, tDCS: 20mins
Intervention Type
Other
Intervention Name(s)
Real-PL training + Sham-NIBS (tDCS)
Intervention Description
PL training : around 40mins, tDCS: 20mins
Intervention Type
Other
Intervention Name(s)
Placebo-PL training + Sham-NIBS (tDCS)
Intervention Description
PL training : around 40mins, tDCS: 20mins
Primary Outcome Measure Information:
Title
Peripheral visual function (high-resolution perimetry & conventional perimetry)
Description
Peripheral visual function will be evaluated monocularly by high-resolution perimetry (HRP) along with conventional perimetry using the program SITA-Standard 24-2 of the HFA. These are two common outcome measures adopted in previous glaucoma RCTs
Time Frame
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
Title
Electroencephalography (EEG)
Description
64-channel electroencephalography(EEG) recordings from Neuroscan will be used to understand the electrophysiological changes in the intervention. A standard visual evoked potential task (VEP) and a specific designed SSVEP task will be used to assess the functional integrity of central vision and peripheral function. Besides, resting-state EEG will be recorded to measure the functional connectivity at different timepoints. ERP components (such as P100, N1 and N2) in VEP, tagging frequency response in SSVEP, and the power correlation in resting state will be analyzed as physiological indicators.
Time Frame
Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
Secondary Outcome Measure Information:
Title
Questionnaires for QoL
Description
National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ 25) and Low Vision Quality of Life (LVQoL) will be used to evaluate the patient-perceived outcome of the intervention on daily living. In NEI-VFQ 25, more positive person measures indicates greater visual ability, and more negative person measures have less visual ability. In the LVQoL, the completion results in a summed score between 0 (a low quality of life) and 125 (a high quality of life).
Time Frame
Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
Title
Balance function
Description
Balance function will be evaluated for the following two conditions:
Static Balance: Participants will be asked to stand on a force place with a foam while performing visual searching. Parameters including maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Perturbed Balance: Participants will be asked to stand on a force place which will translate forward or backward while performing visual searching. Parameters including latency (ms) reacting to the perturbation, maximum antero-posterior amplitude (mm), maximum medio-lateral amplitude (mm), total sway path (mm), and root mean square sway (mm/s) will be analyzed.
Time Frame
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
Title
Gait Test
Description
All participants will be asked to walk along a 7-m walkway at their normal pace. Two disturbing factors will be introduced while walking: visual searching task and obstacle crossing. For trials with visual search, visual stimuli will be presented on the monitor (located at the end of the walkway) when the participant crosses the obstacle. For trials with obstacle crossing, an obstacle with two different colors (grey for low contrast and yellow for high contrast obstacle) of two different heights (2.5x60x5 cm or 2.5x60x15 cm) are positioned at the middle of the walkway. Participants' gait parameters including hip flexion/extension (degree), knee Min/Max (degree), ankle flexion/extension (degree), head flexion/extension (degree), walking speed (mm/s), step width (mm), and toe clearance(mm) will be measured and analyzed for each condition.
Time Frame
Change from baseline at 15weeks, change from baseline at 19weeks, changes from baseline at 23weeks
Title
Questionnaire of psychological state
Description
Perceived Stress Scale (PSS-10) and Patient Health Questionnaire - 9 (PHQ9) will be used to evaluated the stress and depression severity of the outcome of the intervention of participant. Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress. In PHQ9, the completion results in a summed score between 0 (none minimal) to 27 (severe).
Time Frame
Change from baseline at 15weeks, change from baseline at 19weeks, change from baseline at 23weeks.
Other Pre-specified Outcome Measures:
Title
Magnetic resonance spectroscopy (Optional)
Description
Magnetic resonance spectroscopy (MRS) is a non-invasive imaging technique that can be used to study the chemical composition of tissues, including the brain. Changes in GABAergic and Glutamatergic concentrations within the MRS voxels will be used to evaluate the mechanistic changes in the brain. To study the mechanism of glaucoma, we plan to use MEGA-PRESS in primary visual cortex(V1) of the brain to understand the neural and metabolic mechanisms.
Time Frame
Change from baseline at 15 weeks
Title
BDNF concentration in serum and tears (Optional)
Description
Serum BDNF concentration will be measured using an enzyme-linked immunoassay (ELISA) kit and liquid chromatography-mass spectrometry(LCMS). DNA will be extracted from the leucocytes for the determination of BDNF Val66Met polymorphism (rs6265G>A) using a method based on polymerase chain reaction (PCR).
Collection of tear sample by capillary tube (10 ul) or Schirmer Strip in labelled eppendorf tube and keep them frozen immediately. Tear BDNF concentration will be measured using an enzyme-linked immunoassay (ELISA) kit and liquid chromatography-mass spectrometry.
Time Frame
Change from baseline at 15 weeks
Title
Cortisol concentration in serum and tears (Optional)
Description
Cortisol concentration will be measured using an enzyme-linked immunoassay (ELISA) kit and liquid chromatography-mass spectrometry(LCMS).
Collection of tear sample by capillary tube (10 ul) or Schirmer Strip in labelled eppendorf tube and keep them frozen immediately. Tear Cortisol concentration will be measured using an enzyme-linked immunoassay (ELISA) kit and liquid chromatography-mass spectrometry.
Time Frame
Change from baseline at 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Cheong, PhD
Phone
852-27666108
Email
allen.my.cheong@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Melinna Mei, PhD
Phone
852-34002309
Email
melinna.mei@polyu.edu.hk
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allen Cheong, PhD
Phone
852-27666108
Email
allen.my.cheong@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Melinna Mei, PhD
Phone
852-34002309
Email
melinna.mei@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
available: 3mths after data complication
IPD Sharing Access Criteria
The requestor's affiliation and purpose are required to get the access.
Learn more about this trial
Effectiveness of NIBS and Perceptual Learning for Improving Visual Performance in Patients With Glaucoma
We'll reach out to this number within 24 hrs