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GlaucomaNCT07771699

Cross-modal Neuromodulation to Improve Balance and Cognition in Older Adults With Glaucoma: A Randomized Trial of Cerebellar Transcranial Electrical Stimulation

A study testing transcranial electrial stimulation in people with Glaucoma, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to use different tES techniques to constantly stimulate the cerebellum in older glaucoma patients. The main questions aim to answer : 1. If the different types of tES targeting the cerebellum can modulate glaucoma patients' balance function and visual-cognitive function? 2. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Glaucoma
What is being tested?
transcranial electrial stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteHong Kong
Study dates
1 Jul 2026to 1 Nov 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 55 years old;
  • Diagnosis of primary open-angle or normal-tension glaucoma with relative scotoma in both eyes;
  • Humphrey Field Analyzer visual field loss (mean deviation of ≤- 6 dB) using the 24-2 testing protocol for both eyes;
  • Best-corrected distance visual acuity of 6/12 (equivalent to 0.3 logMAR) or better;
  • Cognitive functional score of 22 or above in the Montreal Cognitive Assessment -Hong Kong version (HK-MoCA).
  • Only the right-handed population will be recruited (screening by the Edinburgh Handedness Inventory).

Who cannot join

  • Have musculoskeletal disorders or neurological diseases that can affect the balance or nervous system.
  • Ocular diseases other than glaucoma (e.g., age-related macular degeneration, diabetic retinopathy, moderate to severe cataract) or severe hearing impairment (to ensure that participants can hear the instructions clearly during assessments and training)
  • Have any contraindications for tES

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yihong PENG, Phd student contact

+852-53937970

22117438r@connect.polyu.hk

Hong Kong1 site, 1 recruiting
  • Hong Kong Polytechnic University

    Kowloon, Hong Kong, 000000

    Yihong PENG, phd student, +852-53937970, 22117438r@connect.polyu.hk

    Allen Ming Yan Cheong, PhD

    Recruiting

Other trials in Hong Kong

About this study

The goal of this clinical trial is to use different tES techniques to constantly stimulate the cerebellum in older glaucoma patients. The main questions aim to answer :

  1. If the different types of tES targeting the cerebellum can modulate glaucoma patients' balance function and visual-cognitive function?
  2. Which tES techniques among the two types can benefit most?

Participants will be required to receive the stimulation 15 times (3 sessions, 5 continuous days/session, 1-week interval between each session), and complete the balance and visual-cognitive function outcome measurements before and after each session.

Read the detailed description

Previous research on tES has primarily focused on the effects of different brain cortex stimulation on balance and visual cognitive functions in healthy adults. However, there is a scarcity of research examining the combined effects of these techniques on the cerebellum in visually impaired adults, especially those with glaucoma. Given the cerebellum's crucial role in maintaining balance and cognitive function in glaucoma patients, as evidenced by the latest research, it is essential to determine whether non-invasive cerebellar stimulation can simultaneously improve balance and visual cognitive functions in these patients. Meanwhile, most previous studies only focused on the short-term effects of stimulation, while potential long-term benefits remained unexplored. Our study aims to investigate the long-term effects of two types of tES stimulation on the cerebellum in adults with glaucoma. This research not only aims to fill existing gaps in the literature but also has the potential to develop new intervention strategies to improve functioning in older adults, ultimately enhancing their quality of life.

This study employs a within-subject, sham-controlled, cross-over design. The participants will receive constant tDCS, tACS, and sham stimulation in counterbalanced order. The participants will have three sessions (each session will include five consecutive training sessions) with outcome measurements at six time points. These assessments consist of a baseline test (T1), a test after completing the first session (T2), a test after the first interval week (T3), a test after completing the second session (T4), a test after the second interval week (T5), and a test after completing the third session (T6). The total time will be five weeks.

The outcome measurements will include dynamic balance tests: narrow path walking test and miniBEST test; static balance test: Sensory Organization Test; and two visual cognitive function tests: Reaction Time Test and the Useful Field of View test.

For statistical analysis, IBM SPSS Statistics version 23.0 will be utilized. The Shapiro-Wilk test will be employed to assess the normality of the data distribution. For skewed numerical data, the appropriate transformations will be used to make the data meet the normality assumption. The differences in baseline performance among tACS, tDCS, and sham stimulation were analyzed using repeated-measures ANOVA. To compare the differences between changes in primary and secondary outcomes among baseline and post-intervention time points, the repeated-measures ANOVA will be performed with interventions (tACS, tDCS, and sham) as a within-group factor. Changes in the values will be calculated by subtracting baseline values from the post-intervention values. Paired t-statistics will be obtained to compare the changes in outcome data (subtract baseline from post-intervention) between the interventions (tACS versus tDCS, tACS versus sham, and tDCS versus sham). Post-hoc pairwise comparisons will be performed using Bonferroni corrections. The level of statistical significance is set at p < 0.05.

Conditions
Glaucoma
Being tested
transcranial electrial stimulation
Keywords
balance, glaucoma, visual attention, transcranial electrical stimulation
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial electrial stimulationOther

    This intervention is uniquely designed to enhance balance function in patients with glaucoma using non-invasive cerebellar Transcranial Electrical Stimulation (tES), encompassing both transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS). Glaucoma-induced visual field loss disrupts the visual feedback critical for postural control, forcing patients to rely heavily on sensory re-weighting (integrating vestibular and proprioceptive inputs). The cerebellum is the central hub for this multi-sensory integration and motor adaptation. By modulating cerebellar excitability and neural oscillations, this intervention aims to facilitate sensory re-weighting, optimize vestibular-ocular/spinal reflexes, and ultimately improve dynamic and static balance.

Study groups in NCT07771699
Study groupRoleWhat they receive
tDCSExperimentalThe tDCS stimulation session will be performed over five consecutive days. The tDCS protocol used in this study will involve the application of a low direct current of 2 mA for 20 minutes using a Nurostym tES device (Neuro Device Group SA, Poland). It begins with a 30-second ramp-up period and employs two 5 cm × 5 cm electrodes that are housed in saline-soaked sponges. The anode and the cathode electrodes will be placed bilaterally over the cerebellum (1 cm below the inion of the occipital bone) and the right shoulder, respectively. This electrode montage is based on previous studies and is designed to target cerebellar regions implicated in balance and motor control.
Receives: Other: transcranial electrial stimulation
tACSExperimentalThe tACS stimulation session will be five consecutive days. tACS protocol used in the study will be delivered using the Neurostym tES device (Neuro Device Group SA, Poland) with two 5 × 5 cm electrodes. The anode and the cathode electrodes will be placed bilaterally over the cerebellum (1 cm below the inion of the occipital bone) and the right shoulder, respectively. The tACS will be administered at a current of 2 mA with a stimulation frequency of 50 Hz. There will be a 30-second ramp-up and ramp-down period to minimize discomfort at the onset and offset of stimulation.
Receives: Other: transcranial electrial stimulation
ShamSham comparatorThe sham protocol will mimic the same electrode placement as the other experimental group setting to maintain blinding. During sham stimulation, the stimulator will deliver 2 mA current for the first 30 seconds, after which the current will be turned off for the remainder of the session. To further enhance blinding, the current will be reactivated at 2 mA for the final 30 seconds of the stimulation and then gradually taper off thereafter. The total duration of the sham stimulation will match that of the active stimulation protocols (20 minutes). Each stimulation session will be five consecutive days.
Receives: Other: transcranial electrial stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dynamic Balance Performance-The dual task Narrow Path Walking Test

    The Narrow Path Walking Test (NPWT) is a modified version of the Time Up and Go Test (TUGT) that assesses dynamic balance function during gait in a more challenging environment. In the TUGT, subjects stand up from a 46 cm-tall chair, walk 3 m at their normal walking speed, bypass an obstacle, return, and sit down. NPWT requires participants to perform the same procedure as the TUGT. In NPWT, a 40 x 300 cm green mat with 24% Michelson contrast against the walking path to create a challenging environment, dividing the path into two 20 cm-wide narrow pathways to test mediolateral dynamic balance. The NPWT time will be measured. To add difficulty, the dual task of the serial subtraction will be added in the walking procedure.To achieve stable performance, each test will be repeated 3 times, and the results will be averaged to ensure consistency. The recording parameters for NPWT will include trial time, mistakes, cognitive performance, and dual-task cost.

    Measured: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.

Secondary outcomes (4)
  1. Balance performance - Mini-BESTest

    The Mini-BESTest will be utilized to assess participants' balance through a series of 14 tasks that encompass both static and dynamic balance challenges, including activities such as sit-to-stand, walking with head turns, standing on one leg, and Time up and Go with a dual task. Each task is scored on a scale from 0 to 2, with higher scores reflecting superior balance abilities. To provide a comprehensive evaluation, we will include variations in task difficulty, enabling us to analyze how different levels of complexity influence balance performance. The total score from the Mini-BESTest will be examined to gauge participants' balance proficiency and to identify any improvements resulting from the intervention. All tasks will be administered in a standardized sequence, ensuring a systematic and reliable approach to balance assessment for all participants.

    Measured: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.

  2. Sensory Organization Test

    The SOT provides a quantitative assessment of an individual's ability to utilize specific sensory cues to maintain stability during quiet stance. The protocol consists of six standardized conditions designed to systematically disrupt or isolate sensory information: (1) eyes open, firm surface; (2) eyes closed, firm surface; (3) sway-referenced vision, firm surface; (4) eyes open, sway-referenced surface; (5) eyes closed, sway-referenced surface; and (6) sway-referenced vision and surface. During the assessment, participants will be instructed to stand still with their feet shoulder-width apart for 20 seconds per trial. The primary outcome measures include the Composite Equilibrium Score, representing a weighted average of postural stability across all conditions, and Sensory Analysis Ratios, which are calculated to pinpoint specific impairments in the visual, somatosensory, and vestibular systems.

    Measured: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.

  3. Visual cognitive function-Useful Field of View test

    The UFOV test will include three conditions:

    1. Stimulus Identification: A central target will be displayed on the screen for 60 frames, before being masked by a 'white noise' screen. The display duration will be adjusted using a 3-up/1-down adaptive staircase procedure to determine the threshold, with testing concluding after eight reversals or seventy-two total trials.
    2. Divided Attention: Both a central and a peripheral target will be displayed simultaneously, the latter appearing randomly at one of eight meridian locations (0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°, 360°) at 20° from the center. The presentation duration will be adjusted using the algorithm as in test 1 to reach a threshold.
    3. Selective Attention: This condition will include a central target, a peripheral target, and additional peripheral distractors. The distractors will subtend the same visual angle as the peripheral target. Apart from the introduction of distractors, the procedure is the same as for test 2.

    Measured: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.

  4. Visual cognitive function-reaction time test

    The total Reaction Time Test will be divided into two parts. The first part will involve a simple reaction assessment, utilizing Python software to create the stimulus.

    Participants will be instructed to respond to a stimulus shown in the center of the screen. The second part of the test will involve a choice reaction test, in which four squares will be arranged horizontally on the screen. The stimulus will appear randomly in one of the squares, and the participants will be guided to react to the position as quickly as possible. For the first part, the corresponding time to the stimulus will be recorded. For the second part, the reaction time to the stimulus and the task accuracy will be recorded. Each part will be repeated 3 times to get the average score.

    Measured: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Jul 2026
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771699
Sponsor's protocol ID
HSEARS20250611004
Status last verified
Aug 2026
First submitted
28 Jul 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in publication will be available upon reasonable request to the research team

Questions about this trial

What is this clinical trial studying?

A study testing transcranial electrial stimulation in people with Glaucoma, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yihong PENG, Phd student (+852-53937970, 22117438r@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic Balance Performance-The dual task Narrow Path Walking Test (time frame: The outcome will be assessed 6 times: before and after each stimulation session (tDCS, tACS, Sham session ) (each session length = 5 consecutive days). Therefore, there will be tDCS-pre, tDCS-post; tACS-pre, tACS-post; Sham-pre, Sham-post.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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